510(k) K052190 ยท HGM System, Monitoring, Perinatal
FETAL MONITOR, MODELS BT-300 AND BT-200
| Applicant | Bistos Co., Ltd., Flintville TN, US |
| Decision | Substantially Equivalent, Oct 4, 2005 |
| Received | Aug 11, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052190
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.