510(k) K121267 ยท HGM System, Monitoring, Perinatal
BT-200V VASCULAR DOPPLER
| Applicant | Bistos Co., Ltd., Paterson NJ, US |
| Decision | Substantially Equivalent, Aug 2, 2012 |
| Received | Apr 26, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121267
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.