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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Auditory, Evoked Response
510(k) Number K073626
Device Name BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
Applicant
Bio-Logic Systems Corp.
One Biologic Plaza
Mundelein,  IL  60060
Applicant Contact NICOHL WILDING
Correspondent
Bio-Logic Systems Corp.
One Biologic Plaza
Mundelein,  IL  60060
Correspondent Contact NICOHL WILDING
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received12/26/2007
Decision Date 02/05/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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