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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 K021325
Device Name MODIFICATION OF APEXPRO TELEMETRY SYSTEM
Applicant
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 WEST TOWER AVE.
milwaukee,  WI  53223
Applicant Contact joelle neider
Correspondent
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 WEST TOWER AVE.
milwaukee,  WI  53223
Correspondent Contact joelle neider
Regulation Number870.1025
Classification Product Code
MHX  
Date Received04/26/2002
Decision Date 05/07/2002
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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