510(k) K063510 ยท MKJ Automated External Defibrillators (Non-Wearable)
LIFEPAK 12 DEFIBRILLATOR/MONITOR
| Applicant | Medtronic Emergency Response Systems, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Jan 26, 2007 |
| Received | Nov 20, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063510
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2010 | Physio Control, Inc. Biphasic LIFEPAK 12 defibrillator / monitor. Terminated |
MKJ | None listed |
| Sep 16, 2008 | Physio Control, Inc. Physio-Control LIFEPAK 12 defibrillator/monitor is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Terminated |
LDD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.