510(k) K141194 ยท HGM System, Monitoring, Perinatal
FM-3000 FETAL MONITOR
| Applicant | Advanced Instrumentations, Inc., Hialeah FL, US |
| Decision | Substantially Equivalent, Nov 19, 2014 |
| Received | May 8, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141194
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.