The following data is part of a premarket notification filed by Epcom Medical Systems, Inc. with the FDA for Epcom Ems-180 Antepartum Fetal Monitor.
| Device ID | K813007 |
| 510k Number | K813007 |
| Device Name: | EPCOM EMS-180 ANTEPARTUM FETAL MONITOR |
| Classification | System, Monitoring, Perinatal |
| Applicant | EPCOM MEDICAL SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-27 |
| Decision Date | 1981-12-10 |