510(k) K110742 ยท MKJ Automated External Defibrillators (Non-Wearable)
ONESTEP ADULT MULTI-FUNCTION ELECTRODE
| Applicant | ZOLL Medical Corporation, Pawtucket RI, US |
| Decision | Substantially Equivalent, Apr 13, 2011 |
| Received | Mar 17, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110742
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 4, 2017 | ZOLL Medical Corporation OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 8900 0224 01 (single electrode, UDI: 00847946016272)
Product U Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.