510(k) K860237 ยท HGM System, Monitoring, Perinatal
OMF-7101 FETAL MONITOR
| Applicant | Nihon Kohden America, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Sep 5, 1986 |
| Received | Jan 23, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860237
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.