510(k) K052057 ยท MKJ Automated External Defibrillators (Non-Wearable)
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
| Applicant | Medtronic Emergency Response Systems, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Feb 17, 2006 |
| Received | Jul 29, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052057
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2020 | Physio-Control, Inc. LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED is a semi-automatic defibrillator that uses a pa Terminated |
MKJ | None listed |
| Jul 19, 2013 | Physio Control, Inc. The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) Terminated |
MKJ | None listed |
| Jul 26, 2011 | Physio Control, Inc. The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System.
This software algorithm analyzes the patient's electrocardiographic (E Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.