510(k) K011784 ยท DSI Detector And Alarm, Arrhythmia
MODIFICATION TO ENVOY PATIENT MONITOR
| Applicant | Mennen Medical , Ltd., Rehovot, IL |
| Decision | Substantially Equivalent, Aug 16, 2001 |
| Received | Jun 8, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011784
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.