510(k) K040637 ยท MKJ Automated External Defibrillators (Non-Wearable)
POWERHEART AED G3 PRO
| Applicant | Cardiac Science, Inc., Edina MN, US |
| Decision | Substantially Equivalent, Aug 6, 2004 |
| Received | Mar 10, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040637
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Jan 15, 2005 | Cardiac Science, Inc. Powerheart AED G3 Automated External Defibrillator Model 9300P Professional series). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.