510(k) K000815 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A)
| Applicant | Datex-Ohmeda, Tewksbury MA, US |
| Decision | Substantially Equivalent, Jun 8, 2000 |
| Received | Mar 13, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000815
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.