510(k) K955931 ยท HGM System, Monitoring, Perinatal
MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)
| Applicant | Advanced Medical Systems, Inc., Hamden CT, US |
| Decision | Substantially Equivalent, Aug 14, 1996 |
| Received | Dec 15, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955931
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.