510(k) K994008 ยท HGM System, Monitoring, Perinatal
BIOSYS FETAL MONITOR, MODEL IFM-500
| Applicant | Biosys Co. , Ltd., San Leandro CA, US |
| Decision | Substantially Equivalent, Sep 29, 2000 |
| Received | Nov 24, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994008
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.