510(k) K983395 ยท HGM System, Monitoring, Perinatal
FETALGARD 3000 FETAL MONITOR
| Applicant | Analogic Corp., Peabody MA, US |
| Decision | Substantially Equivalent, Aug 12, 1999 |
| Received | Sep 25, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983395
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.