510(k) K021453 ยท MKJ Automated External Defibrillators (Non-Wearable)
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A
| Applicant | Philips Medical Systems, Andover MA, US |
| Decision | Substantially Equivalent, Jul 3, 2002 |
| Received | May 6, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021453
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2020 | Philips North America, LLC Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator
Switchless: M1741A, M1742A, M1743A, M1744A
Switched: M4741A, M4742A, M Terminated |
MKJ | None listed |
| Oct 4, 2012 | Philips Healthcare Inc. Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries
The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical Terminated |
MKJ | None listed |
| Mar 15, 2010 | Philips Healthcare Inc. Philips Switched Internal Defibrillator Paddles (used with Philips HeartStart XL and HeartStart MRx monitor/defibrillators) used during open heart surgery.
Models:
M4741A - Extra Large Switched inte Terminated |
MKJ | None listed |
| May 19, 2009 | Philips Healthcare Inc. HeartStart XL Model M4735A Defibrillator, Automatic, External
Defibrillator-Monitor.
The defibrillator/monitor is a fully featured defibrillator intended for use by qualified medical personnel train Terminated |
MKJ | None listed |
| Oct 25, 2007 | Philips Medical Systems HeartStart XL Defibrillator/Monitor, Model: M4735A Terminated |
MKJ | None listed |
| Aug 7, 2007 | Philips Medical Systems Philips Medical HeartStartXL Defibrillator/Monitor
Model : M4735A Terminated |
MKJ | None listed |
| Sep 11, 2003 | Philips Medical Systems Model M4735A HeartStart XL Defibrillator//Monitor 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.