The following data is part of a premarket notification filed by Epcom Medical Systems, Inc. with the FDA for Epcom Ems-310 Intrapartum Monitor.
| Device ID | K831113 |
| 510k Number | K831113 |
| Device Name: | EPCOM EMS-310 INTRAPARTUM MONITOR |
| Classification | System, Monitoring, Perinatal |
| Applicant | EPCOM MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-05 |
| Decision Date | 1983-08-12 |