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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 SOUTH SECOND ST.
DEER PARK,  NY  11729
Applicant Contact HOWARD BAILIN
Correspondent
BIO-LOGIC DEVICES
62M SOUTH 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
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