510(k) K945099 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
PARAMETERS MONITORES
| Applicant | Ivy Biomedical Systems, Inc., Branford CT, US |
| Decision | Substantially Equivalent, Jul 13, 1995 |
| Received | Oct 18, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945099
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.