510(k) K001120 ยท DSI Detector And Alarm, Arrhythmia
ENVOY PATIENT MONITOR
| Applicant | Mennen Medical , Ltd., Rehovot, IL |
| Decision | Substantially Equivalent, May 8, 2001 |
| Received | Apr 7, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001120
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.