510(k) K001725 ยท MKJ Automated External Defibrillators (Non-Wearable)
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A
| Applicant | Agilent Technologies, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Sep 8, 2000 |
| Received | Jun 6, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001725
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2020 | Philips North America, LLC Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by tra Terminated |
MKJ | None listed |
| 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.