510(k) K010634 ยท MKJ Automated External Defibrillators (Non-Wearable)
HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B
| Applicant | Agilent Technologies, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Jun 11, 2001 |
| Received | Mar 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010634
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2002 | Philips Medical Systems, Inc. Cardiac & Monitoring Systems Philips HeartStart XL, Model M4735A Defibrillator/Monitor Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.