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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K032369
Device Name MODIFICATION TO: APEXPRO TELEMETRY SYSTEM
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 Number870.1025
Classification Product Code
MHX  
Date Received08/01/2003
Decision Date 08/15/2003
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
Recalls CDRH Recalls
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