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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K032346
Device Name UNITY NETWORK IS PATIENT VIEWER
Applicant
Ge Medical Systems Information Technologies
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact DIANA M THORSON
Correspondent
Ge Medical Systems Information Technologies
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact DIANA M THORSON
Regulation Number870.2300
Classification Product Code
MSX  
Date Received07/30/2003
Decision Date 08/05/2003
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
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