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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K880916
Device Name M444 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 Number882.5050
Classification Product Code
HCC  
Date Received03/03/1988
Decision Date 05/11/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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