510(k) K991910 ยท MKJ Automated External Defibrillators (Non-Wearable)
LIFEPAK 12 BIPHASIC
| Applicant | Physio-Control Corp., Redmond WA, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Sep 3, 1999 |
| Received | Jun 7, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991910
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2008 | Physio Control, Inc. Physio-Control LIFEPAK 12 defibrillator/monitor. The LIFEPAK12 defibrillator/monitor series is a battery operated portable external defibrillator with monitor used by healthcare providers in EMS, hos Terminated |
MKJ | None listed |
| Feb 3, 2005 | Medtronic Emergency Response Systems, Inc. LIFEPAK 12 defibrillator/ monitors biphasic 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.