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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 K033365
Device Name APEXPRO FH 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 Received10/21/2003
Decision Date 11/06/2003
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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