510(k) K010918 ยท MKJ Automated External Defibrillators (Non-Wearable)
LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM
| Applicant | Medtronic Physio-Control Corp., Redmond WA, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Aug 23, 2001 |
| Received | Mar 27, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010918
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 4, 2011 | Physio Control, Inc. The LIFEPAK12 Defibrillator/Monitor.
The LIFEPAK12 Defibrillator/Monitor can be used in AED mode, manual mode or advisory mode. In AED mode, the LIFEPAK 12 is intended for use by personnel who are aut Terminated |
MKJ | None listed |
| Apr 4, 2006 | Medtronic Emergency Response Systems, Inc. LIFEPAK 12 defibrillator/monitor Terminated |
MKJ | None listed |
| Oct 4, 2005 | Medtronic Emergency Response Systems, Inc. Hard shell carry case for the LIFEPAK 500 AED. Terminated |
MKJ | None listed |
| 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.