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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 K111614
Device Name CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE
Applicant
GE HEALTHCARE INTEGRATED IT SOLUTIONS
540 W. NW HIGHWAY
BARRINGTON,  IL  60010
Applicant Contact JEME WALLACE
Correspondent
GE HEALTHCARE INTEGRATED IT SOLUTIONS
540 W. NW HIGHWAY
BARRINGTON,  IL  60010
Correspondent Contact JEME WALLACE
Regulation Number884.2740
Classification Product Code
HGM  
Subsequent Product Code
MSX  
Date Received06/08/2011
Decision Date 09/26/2011
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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