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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 K121208
Device Name OBIX PERINATAL DATA SYSTEM 7.0
Applicant
CLINICAL COMPUTER SYSTEMS, INC.
715 TOLLGATE RD.
UNIT H
ELGIN,  IL  60123 -9331
Applicant Contact CYNTHIA BELL
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact WILLIAM SAMMONS
Regulation Number884.2740
Classification Product Code
HGM  
Date Received04/20/2012
Decision Date 06/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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