510(k) K042007 ยท MKJ Automated External Defibrillators (Non-Wearable)
ZOLL E SERIES DEFIBRILLATOR
| Applicant | Zoll Medical Corp, Chelsmford MA, US |
| Decision | Substantially Equivalent, Apr 7, 2005 |
| Received | Jul 26, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042007
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 25, 2011 | ZOLL Medical Corporation Zoll E Series BLS Defibrillator/Pacemaker/Monitor
Software versions 7.10 and 7.11
The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rh Terminated |
MKJ | None listed |
| May 7, 2010 | ZOLL Medical Corporation, World Wide Headquarters ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Zoll Medical Corporation, Chelmsford, MA.
Intended for the purpose of converting ventricular fi Terminated |
MKJ | None listed |
| Jun 28, 2008 | ZOLL Medical Corporation, World Wide Headquarters Zoll E Series Defibrillator with 12 Lead ECG, Automated external defibrillator, Software Version 3.00 and higher; Zoll Medical Corporation, Chelmsford, MA 01824. Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.