510(k) K130684 ยท MKJ Automated External Defibrillators (Non-Wearable)
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
| Applicant | Philips Medical Systems, Bothell WA, US |
| Decision | Substantially Equivalent, Oct 18, 2013 |
| Received | Mar 13, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130684
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2018 | Philips Electronics North America Corporation Philips QCPR Meter - used with FR3
Product Usage:
The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on Terminated |
LIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.