510(k) K150398 ยท HGM System, Monitoring, Perinatal
EUM 100Pro
| Applicant | Ob Tools, Ltd., Migdal Ha-Emek, IL |
| Decision | Substantially Equivalent, Aug 6, 2015 |
| Received | Feb 18, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150398
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.