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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Cathode-Ray Tube, Medical
510(k) Number K133882
Device Name CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)
Applicant
Ge Medical Systems Information Technologies, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact ROBERT CASARSA
Correspondent
Ge Medical Systems Information Technologies, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact ROBERT CASARSA
Regulation Number870.2450
Classification Product Code
DXJ  
Subsequent Product Codes
BSE   BZQ   CBQ   CBR   CBS  
CCI   CCK   CCL   DOA   DPT   DSB  
DSK   DXN   FLL   GWQ   JEG   NHO  
NHP   NHQ  
Date Received12/20/2013
Decision Date 04/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
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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