510(k) K133659 ยท MKJ Automated External Defibrillators (Non-Wearable)
HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING
| Applicant | Philips Medical Systems, Bothell WA, US |
| Decision | Substantially Equivalent, Jan 23, 2015 |
| Received | Nov 27, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133659
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.