510(k) K012428 ยท MKJ Automated External Defibrillators (Non-Wearable)
MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
| Applicant | Medtronic Physio-Control Corp., Redmond WA, US |
| Decision | Substantially Equivalent, Sep 28, 2001 |
| Received | Jul 31, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012428
| 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 |
| Jul 20, 2004 | Medtronic Physio Control Corp LIFEPAK 500 automated external defibrillator Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.