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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
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