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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 K080251
Device Name APEXPRO TELEMETRY SYSTEMS
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 WEST TOWER AVE.
milwaukee,  WI  53223
Applicant Contact bernard sandler
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 WEST TOWER AVE.
milwaukee,  WI  53223
Correspondent Contact bernard sandler
Regulation Number870.1025
Classification Product Code
MHX  
Date Received01/31/2008
Decision Date 06/20/2008
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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