510(k) K103545 ยท HGM System, Monitoring, Perinatal
BT-350
| Applicant | Bistos Co., Ltd., Brooklyn NY, US |
| Decision | Substantially Equivalent, May 13, 2011 |
| Received | Dec 2, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103545
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.