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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, cutaneous
510(k) Number K941799
Device Name DISPOSABLE CUTANEOUS ELECTRODES
Applicant
BIO-LOGIC SYSTEMS CORP.
ONE BIO-LOGIC PLAZA
MUNDELEIN,  IL  60060 -3700
Applicant Contact RON ROLFSEN
Correspondent
BIO-LOGIC SYSTEMS CORP.
ONE BIO-LOGIC PLAZA
MUNDELEIN,  IL  60060 -3700
Correspondent Contact RON ROLFSEN
Regulation Number882.1320
Classification Product Code
GXY  
Subsequent Product Code
GWQ  
Date Received04/12/1994
Decision Date 02/03/1995
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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