510(k) K043597 ยท HGM System, Monitoring, Perinatal
FC 700 FETAL MONITOR
| Applicant | Bionet Co., Ltd., Wonju, Kwangwon-Do, KR |
| Decision | Substantially Equivalent, Dec 16, 2005 |
| Received | Dec 29, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043597
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.