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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 K051175
Device Name CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION
Applicant
Civent Communications, Ltd.
Meshek 58
Ben Nnatan
Moshav Hemed,  IL 50295
Applicant Contact RUDI LOKITS
Correspondent
Civent Communications, Ltd.
Meshek 58
Ben Nnatan
Moshav Hemed,  IL 50295
Correspondent Contact RUDI LOKITS
Regulation Number884.2740
Classification Product Code
HGM  
Date Received05/06/2005
Decision Date 02/17/2006
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
Recalls CDRH Recalls
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