510(k) K861556 ยท HGM System, Monitoring, Perinatal
MODIFIED FETAL MONITOR MODEL FM-2
| Applicant | Advantage Medical Systems, Inc., Hamden CT, US |
| Decision | Substantially Equivalent, Jul 7, 1986 |
| Received | Apr 25, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861556
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.