510(k) K052161 ยท MKJ Automated External Defibrillators (Non-Wearable)
POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)
| Applicant | Cardiac Science, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Oct 21, 2005 |
| Received | Aug 9, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052161
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| 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 GE Responder 2019198 AED Manufactured for GE Medical Systems Information Technologies by Cardiac Science Corporation, Automated External Defibrillator Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.