The following data is part of a premarket notification filed by Promedic, Inc. with the FDA for Eum 100pro.
| Device ID | K131889 |
| 510k Number | K131889 |
| Device Name: | EUM 100PRO |
| Classification | Uterine Electromyographic Monitor |
| Applicant | PROMEDIC, INC. 24301 WOODSAGE DR Bonita Springs, FL 34134 -2958 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden PROMEDIC, INC. 24301 WOODSAGE DR Bonita Springs, FL 34134 -2958 |
| Product Code | OSP |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-25 |
| Decision Date | 2014-04-23 |
| Summary: | summary |