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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 K021801
Device Name BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
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  
Subsequent Product Code
GWJ  
Date Received06/03/2002
Decision Date 06/27/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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