510(k) K011901 ยท MKJ Automated External Defibrillators (Non-Wearable)
FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200
| Applicant | Survivalink Corp., Minnetonka MN, US |
| Decision | Substantially Equivalent, Feb 1, 2002 |
| Received | Jun 18, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011901
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Cardiac Science, Inc. Power Heart AED Automatic External Defibrillator, Model 9200 RD Terminated |
MKJ | None listed |
| Jul 20, 2004 | Cardiac Science, Inc. Power Heart Automatic External Defibrillator, Model 9210 RD Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.