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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 K964132
Device Name MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT
Applicant
BIO-LOGIC SYSTEMS CORP.
ONE BIO-LOGIC PLAZA
MUNDELEIN,  IL  60060 -3700
Applicant Contact NORMAN E BRUNNER
Correspondent
BIO-LOGIC SYSTEMS CORP.
ONE BIO-LOGIC PLAZA
MUNDELEIN,  IL  60060 -3700
Correspondent Contact NORMAN E BRUNNER
Regulation Number874.1050
Classification Product Code
EWO  
Date Received10/15/1996
Decision Date 05/13/1997
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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