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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 WEST TOWER AVE.
milwaukee,  WI  53223
Applicant Contact diana m thorson
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 WEST 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
Recalls CDRH Recalls
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