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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
Original Applicant
BIO-LOGIC SYSTEMS CORP.
one biologic plaza
mundelein,  IL  60060
Original Contact timothy karlovsky
Regulation Number874.1050
Classification Product Code
EWO  
Date Received08/16/2012
Decision Date 11/01/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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