510(k) K000517 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
LIFE SCOPE EC, MODEL BSM-1102
| Applicant | Nihon Kohden America, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Aug 31, 2000 |
| Received | Feb 16, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000517
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.