510(k) K112998 ยท DRM Compressor, Cardiac, External
AUTOPULSE RESUSCITATION SYSTEM MODEL 1000
| Applicant | Zoll Circulation, San Jose CA, US |
| Decision | Substantially Equivalent, Mar 15, 2012 |
| Received | Oct 7, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112998
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2022 | ZOLL Circulation, Inc. AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR Open, Classified |
DRM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.