510(k) K112317 ยท HGM System, Monitoring, Perinatal
FM-9000 PLUS FETAL AND MATERNAL MONITOR
| Applicant | Advanced Instrumentations, Inc., Hialeah FL, US |
| Decision | Substantially Equivalent, Dec 21, 2011 |
| Received | Aug 11, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112317
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.