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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 K162012
Device Name CARESCAPE Central Station V2
Applicant
GE HEALTHCARE
8200 WEST TOWER AVE.
MILWAUKEE,  WI  53223
Applicant Contact ROBERT CASARSA
Correspondent
GE HEALTHCARE
8200 WEST TOWER AVE.
MILWAUKEE,  WI  53223
Correspondent Contact ROBERT CASARSA
Regulation Number870.2450
Classification Product Code
DXJ  
Subsequent Product Codes
DQK   DSI  
Date Received07/21/2016
Decision Date 09/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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