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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 K864660
Device Name MODEL M402 EMG MONITOR
Applicant
Bio-Logic Devices
62m S. Second St.
Deer Park,  NY  11729
Applicant Contact HOWARD BAILIN
Correspondent
Bio-Logic Devices
62m S. Second St.
Deer Park,  NY  11729
Correspondent Contact HOWARD BAILIN
Regulation Number890.1375
Classification Product Code
IKN  
Date Received11/28/1986
Decision Date 02/04/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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