510(k) K112432 ยท MKJ Automated External Defibrillators (Non-Wearable)
ZOLL X SERIES
| Applicant | Zoll Medical Corporation, World Wide Headquarters, Chelsmford MA, US |
| Decision | Substantially Equivalent, Mar 21, 2012 |
| Received | Aug 23, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112432
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2014 | ZOLL Medical Corporation Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator. Terminated |
MKJ | None listed |
| Sep 17, 2012 | ZOLL Medical Corporation Zoll X Series Defibrillator/Pacemaker/Monitor
Product Usage:
The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.