510(k) K050004 ยท MKJ Automated External Defibrillators (Non-Wearable)
PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304
| Applicant | Philips Medical Systems, Seattle WA, US |
| Decision | Substantially Equivalent, Feb 25, 2005 |
| Received | Jan 2, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050004
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2019 | Philips North America LLC Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017 Terminated |
MKJ | None listed |
| Sep 10, 2019 | Philips North America LLC Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063 Terminated |
MKJ | None listed |
| Mar 14, 2018 | Philips Electronics North America Corp. Philips HeartStart FRx AED. Terminated |
MKJ | None listed |
| Jan 4, 2013 | Philips Medical Systems North America Co. Phillips Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305
The FRx Defibrillator is intended to trea Terminated |
MKJ | None listed |
| Nov 22, 2010 | Philips Medical Systems Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog number 861304. Terminated |
MKJ | None listed |
| Jun 28, 2010 | Philips Medical Systems Automated External Defibrillator (AED) of brand name "Philips HeartStart FRx" (Model number 861304).
Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken an Terminated |
MKJ | None listed |
| Mar 23, 2010 | Philips Medical Systems Philips Heartstart FRx automated external defibrillator (AED), Model 861304 Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.