510(k) K082937 ยท MKJ Automated External Defibrillators (Non-Wearable)
LIFEPAK 15 MONITOR/DEFIBRILLATOR
| Applicant | Physio-Control, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Mar 11, 2009 |
| Received | Oct 1, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082937
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2010 | Physio Control, Inc. Biphasic LIFEPAK 15 Monitor/Defibrillator. Manufactured by Physio-Control Inc., a division of Medtronic, Inc. Redmond, Washington USA.
The LIFEPAK 15 monitor/defibrillator is a complete acute cardi Terminated |
MKJ | None listed |
| Mar 11, 2010 | Physio-Control, Inc. The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical
personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers Terminated |
MKJ | None listed |
| Sep 18, 2009 | Physio Control, Inc. Biphasic LIFEPAK 15 Monitor/Defibrillator.
The LIFEPAK 15 is a battery operated monitor with an external portable defibrillator used by healthcare providers in EMS, hospital and clinic settings. It o Terminated |
DXN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.