510(k) K111693 ยท MKJ Automated External Defibrillators (Non-Wearable)
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
| Applicant | Philips Medical Systems, Seattle WA, US |
| Decision | Substantially Equivalent, Oct 28, 2011 |
| Received | Jun 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111693
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2014 | Philips Medical Systems North America Inc. Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389.
The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.