510(k) K891595 ยท HGM System, Monitoring, Perinatal
MODEL 116 FETAL MONITOR
| Applicant | Ge Medical Systems Information Technologies, Wallingford CT, US |
| Decision | Substantially Equivalent, Jun 12, 1989 |
| Received | Mar 20, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891595
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.