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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
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