510(k) K142799 ยท HGM System, Monitoring, Perinatal
Model BT-220L and BT-220C
| Applicant | Bistos Co., Ltd., Ramsey NJ, US |
| Decision | Substantially Equivalent, Jul 9, 2015 |
| Received | Sep 29, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142799
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.