510(k) K982697 ยท DSI Detector And Alarm, Arrhythmia
MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR
| Applicant | Mennen Medical, Inc., Rehovot, IL |
| Decision | Substantially Equivalent, Aug 12, 1998 |
| Received | Aug 3, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K982697
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.