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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K122496
Device Name AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
Applicant
Bio-Logic Systems Corp.
One Biologic Plaza
Mundelein,  IL  60060
Applicant Contact TIMOTHY KARLOVSKY
Correspondent
Bio-Logic Systems Corp.
One Biologic Plaza
Mundelein,  IL  60060
Correspondent Contact TIMOTHY KARLOVSKY
Regulation Number874.1050
Classification Product Code
EWO  
Date Received08/16/2012
Decision Date 11/01/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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