510(k) K102496 ยท MKJ Automated External Defibrillators (Non-Wearable)
POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS
| Applicant | Cardiac Science Corporation, Bothell WA, US |
| Decision | Substantially Equivalent, Jun 9, 2011 |
| Received | Aug 31, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K102496
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 9, 2016 | Cardiac Science Corporation 9131-001 Defibrillation Electrodes, Lot No. 141125-02
Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs
Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be Terminated |
MKJ | None listed |
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.