510(k) K063119 ยท MKJ Automated External Defibrillators (Non-Wearable)
LIFEPAK 20 DEFIBRILLATOR/ MONITOR
| Applicant | Medtronic Emergency Response Systems, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Dec 22, 2006 |
| Received | Oct 12, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063119
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2008 | Physio Control, Inc. Physio-Control LIFEPAK 20 defibrillator/monitor is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Terminated |
LDD | None listed |
| Sep 16, 2008 | Physio Control, Inc. Physio-Control LIFEPAK 20e defibrillator/monitor, sold internationally only, is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomati Terminated |
LDD | None listed |
| Sep 8, 2008 | Physio Control, Inc. Physio-Control LIFEPAK 20 defibrillator/monitor. This product is an external defibrillator sold internationally and domestically. Terminated |
LDD | None listed |
| Sep 8, 2008 | Physio Control, Inc. Physio-Control LIFEPAK 20e defibrillator/monitor. This product is an external defibrillator sold internationally only Terminated |
LDD | None listed |
| Sep 8, 2008 | Physio Control, Inc. Keypad replacement for LIFEPAK20 or LIFEPAK20e. This product is an external defibrillator. Terminated |
LDD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.