510(k) K993608 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR)
| Applicant | Datex-Ohmeda, Inc., Tewksburt MA, US |
| Decision | Substantially Equivalent, Apr 13, 2000 |
| Received | Oct 25, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993608
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.