510(k) K000563 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
MODIFICATION TO ENVOY PATIENT MONITOR
| Applicant | Mennen Medical , Ltd., Rehovot, IL |
| Decision | Substantially Equivalent, May 17, 2000 |
| Received | Feb 22, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K000563
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.