510(k) K012197 ยท MKJ Automated External Defibrillators (Non-Wearable)
POWERHEART CARDIAC RHYTHM MODULE
| Applicant | Cardiac Science, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Nov 16, 2001 |
| Received | Jul 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012197
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2011 | Cardiac Science Corporation Automated External Defibrillator (non-wearable). Model number 9200, 9200N, 9200DN, 9200RD, 9210N, 9210RD, and CardioVive 92530.
The battery component is warranted for 5 years, and electrodes have a Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.