510(k) K042404 ยท MKJ Automated External Defibrillators (Non-Wearable)
LIFEPAK, MODEL 1000
| Applicant | Medtronic Emergency Response Systems, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Dec 22, 2005 |
| Received | Sep 3, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042404
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2014 | Physio-Control, Inc. LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX
The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest. Terminated |
MKJ | None listed |
| Sep 16, 2008 | Physio Control, Inc. LIFEPAK 1000 defibrillator - portable battery powered semi-automated model that can be operated in either of three modes: Automated external defibrillator (AED), manual defibrillator and electrocardio Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.