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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 K880913
Device Name M424 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 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
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