510(k) K100885 ยท HGM System, Monitoring, Perinatal
FETAL MONITOR MODEL: BT-200T
| Applicant | Bistos Co., Ltd., Paterson NJ, US |
| Decision | Substantially Equivalent, Jun 7, 2010 |
| Received | Mar 30, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100885
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.