510(k) K031987 ยท MKJ Automated External Defibrillators (Non-Wearable)
POWERHEART AED G3, MODEL 9300
| Applicant | Cardiac Science, Edina MN, US |
| Decision | Substantially Equivalent, Jul 30, 2003 |
| Received | Jun 27, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031987
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2012 | Cardiac Science Corporation Powerheart G3 Automated External Defibrillators (Non-Wearable) and include the following models: Powerheart 9300A, 9300E, 9300P, 9390A, 9390E; CardioVive 92532, 92533; Nihon-Kohden 9200G, 9231; and GE Terminated |
MKJ | None listed |
| Sep 19, 2011 | Cardiac Science Corporation Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscit Terminated |
MKJ | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Feb 25, 2009 | Cardiac Science Corporation Cardiac Science Powerheart Automated External Defibrillator G3 9300A Terminated |
MKJ | None listed |
| Feb 25, 2009 | Cardiac Science Corporation Cardiac Science First Save Automated External Defibrillator G3 9300C Terminated |
MKJ | None listed |
| Feb 25, 2009 | Cardiac Science Corporation Cardiac Science Powerheart Automated External Defibrillator G3 9300E. Terminated |
MKJ | None listed |
| Feb 25, 2009 | Cardiac Science Corporation Cardiac Science Powerheart Automated External Defibrillator G3 9390A Terminated |
MKJ | None listed |
| Feb 25, 2009 | Cardiac Science Corporation Cardiac Science Powerheart Automated External Defibrillator G3 9390E Terminated |
MKJ | None listed |
| Jan 15, 2005 | Cardiac Science, Inc. Powerheart AED G3 Automated External Defibrillator Model 9300E. Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982. Terminated |
MKJ | None listed |
| Jul 20, 2004 | Cardiac Science, Inc. Power Heart AED G3 Automated External Defibrillator IntelliSense (Lithium) Battery, Model 9142 Terminated |
MKJ | None listed |
| Jul 20, 2004 | Cardiac Science, Inc. FirstSave AED G3 Automated External Defibrillator IntelliSense (Lithium) Battery, Model 9143 Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.