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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name detector and alarm, arrhythmia
510(k) Number K032370
Device Name CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 WEST TOWER AVE.
milwaukee,  WI  53223
Applicant Contact karen m lunde
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 WEST TOWER AVE.
milwaukee,  WI  53223
Correspondent Contact karen m lunde
Regulation Number870.1025
Classification Product Code
DSI  
Subsequent Product Code
DXJ  
Date Received08/01/2003
Decision Date 08/13/2003
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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