510(k) K955854 ยท MKJ Automated External Defibrillators (Non-Wearable)
LIFEPAK 500
| Applicant | Physio-Control Corp., Redmond WA, US |
| Decision | Substantially Equivalent, Nov 4, 1996 |
| Received | Dec 28, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955854
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2020 | Physio-Control, Inc. LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED is a semi-automatic defibrillator that uses a pa Terminated |
MKJ | None listed |
| Aug 4, 2007 | Medtronic Emergency Response Systems, Inc. biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguo Terminated |
MKT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.