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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
Original Applicant
CLINICAL COMPUTER SYSTEMS, INC.
715 tollgate rd.
unit h
elgin,  IL  60123 -9331
Original Contact cynthia bell
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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