510(k) K011144 ยท MKJ Automated External Defibrillators (Non-Wearable)
LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR
| Applicant | Medtronic Physio-Control Corp., Redmond WA, US |
| Decision | Substantially Equivalent, Dec 3, 2001 |
| Received | Apr 16, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011144
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2013 | Physio Control, Inc. The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006.
Automated external defibrillators. Terminated |
MKJ | None listed |
| Sep 14, 2009 | Physio Control, Inc. Medtronic Physio-Control LIFEPAK CR Plus Defibrillator/Monitor.
Automated external defibrillator deployed primarily in public access defibrillator environments where the expected use for any one devi Terminated |
MKJ | None listed |
| Oct 30, 2008 | Physio Control, Inc. LIFEPAK CR Plus Automated External Defibrillator (AED). Labeling on the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Sys Terminated |
MKJ | None listed |
| Oct 30, 2008 | Physio Control, Inc. LIFEPAK Express Automated External Defibrillator (AED). Labeling on the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Sys Terminated |
MKJ | None listed |
| Sep 16, 2008 | Physio Control, Inc. LIFEPAK CR Plus Automated External Defibrillator. Device is primarily deployed in Public Access Defibrillator (PAD). It is a small lightweight device intended for use by minimally trained responders Terminated |
MJK | None listed |
| Jun 21, 2007 | Medtronic Emergency Response Systems, Inc. LIFEPAK CR Plus defibrillator Terminated |
MKJ | None listed |
| Jun 21, 2007 | Medtronic Emergency Response Systems, Inc. LIFEPAK EXPRESS defibrillator Terminated |
MKJ | None listed |
| Mar 29, 2007 | Medtronic Emergency Response Systems, Inc. LIFEPAK CR Plus defibrillator. The device is a battery operated, portable automated external defibrillator (AED). The devices are designed for non-professional users and are primarily used in public Terminated |
MKJ | None listed |
| Jun 12, 2003 | Medtronic Physio Control Corp LIFEPAK CR Plus defibrillator Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.