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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 Cir., #100
London,  CA N6G 4X8
Applicant Contact ROBERT SNOW
Correspondent
Advantage Medical Division of Cme Telemetrix
100 Collip Cir., #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
Predetermined Change
Control Plan Authorized		 No
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