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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 K974076
Device Name SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE
Applicant
Bio-Logic Systems Corp.
One Bio-Logic Plz.
Mudelein,  IL  60060
Applicant Contact NORMAN E BRUNNER
Correspondent
Bio-Logic Systems Corp.
One Bio-Logic Plz.
Mudelein,  IL  60060
Correspondent Contact NORMAN E BRUNNER
Regulation Number874.1050
Classification Product Code
EWO  
Date Received10/29/1997
Decision Date 01/22/1998
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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