510(k) K060934 ยท MKJ Automated External Defibrillators (Non-Wearable)
MODIFICATION TO POWERHEART ECD
| Applicant | Cardiac Science Corporation, Bothell WA, US |
| Decision | Substantially Equivalent, May 15, 2006 |
| Received | Apr 5, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060934
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2010 | Cardiac Science Corporation GE Responder 2000 Defibrillator/Monitor, models 2025653, 2026109, and 2026114 that were manufactured between July 25, 2008 and October 2, 2009 by GE Healthcare. Terminated |
MKJ | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.