510(k) K911646 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
NGM ESTP MODULE
| Applicant | Datex Division Instrumentarium Corp., Tewksbury MA, US |
| Decision | Substantially Equivalent, Feb 21, 1992 |
| Received | Apr 15, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911646
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.