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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Monitoring, Perinatal
510(k) Number K150398
Device Name EUM 100Pro
Applicant
Ob Tools, Ltd.
Mifaley Haemek Industrial Zone
P.O. Box 667
Migdal Ha-Emek,  IL 2310502
Applicant Contact GAL BEN DAVID
Correspondent
Promedic, Inc.
24301 Woodsage Dr.
Bonita Springs,  FL  34134 -2958
Correspondent Contact PAUL DRYDEN
Regulation Number884.2740
Classification Product Code
HGM  
Subsequent Product Code
OSP  
Date Received02/18/2015
Decision Date 08/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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