510(k) K955559 ยท HGM System, Monitoring, Perinatal
COROMETRICS FETAL MOVEMENT DETECTION KIT
| Applicant | Ge Medical Systems Information Technologies, Wallingford CT, US |
| Decision | Substantially Equivalent, Mar 5, 1996 |
| Received | Dec 6, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955559
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.