510(k) K130454 ยท MKJ Automated External Defibrillators (Non-Wearable)
LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR
| Applicant | Physio-Control, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Aug 21, 2013 |
| Received | Feb 22, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130454
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2018 | Physio-Control, Inc. LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273
Product Usage:
The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are author Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.