510(k) K002445 ยท MKJ Automated External Defibrillators (Non-Wearable)
LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES
| Applicant | Medtronic Physio-Control Corp., Redmond WA, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Jan 31, 2001 |
| Received | Aug 9, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002445
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2003 | Medtronic Physio Control Corp LIFEPAK 12 defibrillator/monitor is a portable, battery operated, complete acute cardiac care response system with both manual and semi-automatic defibrillation operation. It has the ability to exte Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.