510(k) K033275 ยท MKJ Automated External Defibrillators (Non-Wearable)
LIFEPAK 12, 20, 500, CR PLUS
| Applicant | Medtronic Physio-Control Corp., Redmond WA, US |
| Decision | Substantially Equivalent, Nov 6, 2003 |
| Received | Oct 10, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033275
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 25, 2016 | Physio-Control, Inc. LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable.
LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use on patients in cardiac arr Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.