510(k) K110612 ยท HGM System, Monitoring, Perinatal
FM20
| Applicant | Mediana Co., Ltd., Wonju-Si, Gangwon-Do, KR |
| Decision | Substantially Equivalent, Nov 8, 2011 |
| Received | Mar 3, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110612
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.