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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electromyograph, diagnostic
510(k) Number K974010
Device Name ADVANTAGE EMG SYSTEM, MODEL #A100
Applicant
ADVANTAGE MEDICAL DIVISION OF CME TELEMETRIX
100 COLLIP CIRCLE, #100
LONDON,  CA N6G 4X8
Applicant Contact ROBERT SNOW
Correspondent
ADVANTAGE MEDICAL DIVISION OF CME TELEMETRIX
100 COLLIP CIRCLE, #100
LONDON,  CA N6G 4X8
Correspondent Contact ROBERT SNOW
Regulation Number890.1375
Classification Product Code
IKN  
Date Received10/21/1997
Decision Date 01/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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