510(k) K970358 ยท DSI Detector And Alarm, Arrhythmia
ENSEMBLE CENTRAL STATION MONITOR
| Applicant | Mennen Medical, Inc., Rehovot, IL |
| Decision | Substantially Equivalent, Feb 11, 1998 |
| Received | Jan 30, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970358
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.