Panels › Cardiovascular › Product code MKJ · Class 3
Automated External Defibrillators (Non-Wearable)
Regulation 870.5310
0510(k)s in 12 months (228 all time)
4recalls in 12 months (338 all time)
257recalls that name a 510(k)
Top companies in MKJ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2010 | Defibtech, LLC DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillator (AED).
The DDC-6-AA data card is an accessory to the AED and does not have its own intended use. Terminated |
MKJ | K013896 |
| Aug 27, 2010 | Philips Healthcare Inc. HeartStart MRx Defibrillator/Monitor with Q-CPR
Meter option.The HeartStart MRx monitor/defibrillator has an option (Q-CPR Meter) to provide visual and audible feedback to the rescuer on the quality Terminated |
MKJ | K051134 |
| Jul 1, 2010 | Physio Control, Inc. LIFEPAK 20 defibrillator/monitor.
Product Part numbers: 3202487-xxx, 3202488-xxx, U3202487-000, 3202488-015, and U3202488-000. Terminated |
MKJ | K012274 |
| Jun 28, 2010 | Philips Medical Systems Automated External Defibrillator (AED) of brand name "Philips HeartStart HS1 Home" (Model Number M5068A).
Device is designed for use on a person in sudden cardiac arrest who is unresponsive when sha Terminated |
MKJ | K020715 K040904 |
| Jun 28, 2010 | Philips Medical Systems Automated External Defibrillator(AED) of brand name "Philips HeartStart HS1 OnSite" (Model number M5066A).
Device is designed for use on a person in sudden cardiac arrest who is unresponsive when sha Terminated |
MKJ | K020715 |
| Jun 28, 2010 | Philips Medical Systems Automated External Defibrillator (AED) of brand name "Philips HeartStart FRx" (Model number 861304).
Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken an Terminated |
MKJ | K050004 |
| Jun 21, 2010 | Cardiac Science Corporation Cardiac Science Powerheart 9390A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when approp Terminated |
MKJ | K031987 |
| Jun 10, 2010 | Defibtech LLC ReviveR AED semiautomatic external defibrillator used with the DBP-2800 Battery Pack. Manufactured by Defibtech, LLC. Seymour, CT 06483.
The DBP-2800 battery pack is an accessory to the AED and do Terminated |
MKJ | K013896 |
| Jun 10, 2010 | Defibtech LLC Lifeline AED DDU-100 semiautomatic external defibrillator used with the DBP-2800 Battery Pack, Manufactured by Defibtech, LLC. Seymour, CT 06483.
The DBP-2800 battery pack is an accessory to the AE Terminated |
MKJ | K013896 |
| May 26, 2010 | Cardiac Science Corporation Responder 2000 Defibrillator/Monitor
Models: 2025653, 2026109, and 2026114.
Intended use: The Responder 2000 is indicated for the termination of certain fatal arrhythmias, such as ventricular fibrill Terminated |
MKJ | K060934 |
| May 24, 2010 | Philips Healthcare Inc. HeartStart MRx Defibrillator Monitor, Model M3535A
HeartStart MRx Defibrillator Monitor, Model M3536A
The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibr Terminated |
MKJ | K051134 |
| May 7, 2010 | ZOLL Medical Corporation, World Wide Headquarters ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Zoll Medical Corporation, Chelmsford, MA.
Intended for the purpose of converting ventricular fi Terminated |
MKJ | K042007 |
| Apr 27, 2010 | Cardiac Science Corporation Cardiac Science, Automated External Defibrillator (AED) under the following brand names (with respective model numbers): Powerheart AED G3: 9300A, 9300C, 9300D, 9300E, 9300P, 9390A/E; CardioVive: 92 Terminated |
MKJ | K031987 |
| Apr 21, 2010 | Physio Control, Inc. Biphasic LIFEPAK 15 Monitor/Defibrillator. Manufactured by Physio-Control Inc., a division of Medtronic, Inc. Redmond, Washington USA.
The LIFEPAK 15 monitor/defibrillator is a complete acute cardi Terminated |
MKJ | K082937 |
| Apr 9, 2010 | Philips Healthcare Inc. HeartStart MRx Defibrillator Monitor (Models M3535A, M3536A and M3536J) used with Philips 14.8-Volt Lithium Ion Battery (ModeI M3538A).
The HeartStart MRx is for use for the termination of ventricula Terminated |
MKJ | K051134 |
| Apr 8, 2010 | Philips Healthcare Inc. HeartStart MRx- AC power module kit.
For use for the termination of ventricular tachycardia and ventricular fibrillation. Terminated |
MKJ | K051134 |
| Apr 8, 2010 | Philips Healthcare Inc. HeartStart MRx Defibrillator/Monitor.
For use for the termination of ventricular tachycardia and ventricular fibrillation. Terminated |
MKJ | K051134 |
| Apr 8, 2010 | Philips Healthcare Inc. AC power cords manufactured by Electri-Cord with tall bridge design. Used across all Philips product lines, as well as Respironics/Philips products, Dixtel owned products and Dixtal (formerly Novamet Terminated |
MKJ | K051134 |
| Apr 6, 2010 | Cardiac Science Corporation Cardiovive 92532 automated external defibrillator.
This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate).
Br Terminated |
MKJ | K031987 K040438 +3 |
| Apr 6, 2010 | Cardiac Science Corporation Responder 2023440 automated external defibrillator.
This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate).
B Terminated |
MKJ | K031987 K040438 +3 |
| Apr 6, 2010 | Cardiac Science Corporation Powerheart 9390E automated external defibrillator.
This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate).
Br Terminated |
MKJ | K031987 K040438 +3 |
| Apr 6, 2010 | Cardiac Science Corporation Powerheart 9390A automated external defibrillator.
This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when appropriate).
Brand n Terminated |
MKJ | K031987 K040438 +3 |
| Apr 6, 2010 | Cardiac Science Corporation Powerheart 9300P automated external defibrillator.
This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate).
Br Terminated |
MKJ | K031987 K040438 +3 |
| Apr 6, 2010 | Cardiac Science Corporation Powerheart 9300E automated external defibrillator.
This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate).
Br Terminated |
MKJ | K031987 K040438 +3 |
| Apr 6, 2010 | Cardiac Science Corporation Powerheart 9300A automated external defibrillator.
This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when appropriate).
Brand na Terminated |
MKJ | K031987 K040438 +3 |
| Mar 23, 2010 | Philips Medical Systems Heartstart (HS1) Laerdal brand onsite Automated External Defibrillator, Model M5067A Terminated |
MKJ | K020715 |
| Mar 23, 2010 | Philips Medical Systems Philips Heartstart (HS1) Onsite Automated External Defibrillator (AED) Catalog number M5066A Terminated |
MKJ | K020715 |
| Mar 23, 2010 | Philips Medical Systems Philips Heartstart FRx automated external defibrillator (AED), Model 861304 Terminated |
MKJ | K050004 |
| Mar 15, 2010 | Philips Healthcare Inc. Philips Switched Internal Defibrillator Paddles (used with Philips HeartStart XL and HeartStart MRx monitor/defibrillators) used during open heart surgery.
Models:
M4741A - Extra Large Switched inte Terminated |
MKJ | K021453 K031187 |
| Mar 11, 2010 | Physio-Control, Inc. The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical
personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers Terminated |
MKJ | K082937 |
| Mar 4, 2010 | Cardiac Science Corporation NK 9200G. CardioLife automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation NK 9231 CardioLife automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate).
Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation GE Responder 2023440 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation GE Responder 2019198 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation Burdick Cardiovive 92533 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropria Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation Burdick Cardiovive 92532 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropria Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation Burdick Cardiovive 92531 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropria Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation Cardiac Science Powerheart 9390E automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when ap Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation Cardiac Science Powerheart 9390A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when approp Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation Cardiac Science Powerheart 9300P automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation Cardiac Science Powerheart 9300E automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when a Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation Cardiac Science Powerheart 9300D automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when a Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation Cardiac Science Powerheart 9300C automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when a Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation Cardiac Science Powerheart 9300A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when approp Terminated |
MKJ | K031987 K040438 +1 |
| Feb 22, 2010 | Physio Control, Inc. Biphasic LIFEPAK 12 defibrillator / monitor. Terminated |
MKJ | K063510 |
| Dec 23, 2009 | Philips Healthcare Inc. Philips HeartStart Vehicle Wall Mount, Model M5528A
with Philips HeartStart DC Power Module, Model M5529A.
The HeartStart MRx portable external defibrillator has optional accessories which include Terminated |
MKJ | K051134 |
| Dec 8, 2009 | Philips Medical Systems Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the ECG Module.
Model M3861A is under the Philips label and M3841A is under the Laerdal label. Terminated |
MKJ | K051632 |
| Dec 8, 2009 | Philips Medical Systems Heartstart FR2+ automated external defibrillator Models M3860A and M3840A are equipped with an ECG Module. M3860A is under the Philips label and M3840A is under the Laerdal label. Terminated |
MKJ | K051632 |
| Nov 9, 2009 | Philips Healthcare Inc. HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor.
The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualifie Terminated |
MKJ | K031187 |
| Sep 29, 2009 | ZOLL Medical Corporation, World Wide Headquarters ZOLL R Series Defibrillator/Pacemaker/Monitor
Used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing Terminated |
MKJ | K060559 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.