510(k) K081891 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR
| Applicant | Fukuda Denshi USA, Inc., Great Neck NY, US |
| Decision | Substantially Equivalent, Aug 29, 2008 |
| Received | Jul 2, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081891
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.