510(k) K831115 ยท HGM System, Monitoring, Perinatal
EPCOM EMS-320 REMOTE MONITORSCOPE
| Applicant | Epcom Medical Systems, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 12, 1983 |
| Received | Apr 5, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831115
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.