510(k) K030812 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE
| Applicant | Datex-Ohmeda, Needham MA, US |
| Decision | Substantially Equivalent, May 21, 2003 |
| Received | Mar 14, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030812
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.