510(k) K974510 ยท DSI Detector And Alarm, Arrhythmia
ENVOY PATIENT MONITOR
| Applicant | Mennen Medical, Inc., Rehovot, IL |
| Decision | Substantially Equivalent, Apr 14, 1998 |
| Received | Dec 1, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974510
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.