The following data is part of a premarket notification filed by Ob Tools, Ltd. with the FDA for Eum 100pro.
| Device ID | K150398 |
| 510k Number | K150398 |
| Device Name: | EUM 100Pro |
| Classification | System, Monitoring, Perinatal |
| Applicant | OB TOOLS, LTD. MIFALEY HAEMEK INDUSTRIAL ZONE P.O. BOX 667 Migdal Ha-emek, IL 2310502 |
| Contact | Gal Ben David |
| Correspondent | Paul Dryden PROMEDIC, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 -2958 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-18 |
| Decision Date | 2015-08-06 |
| Summary: | summary |