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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 K943616
Device Name BELTONE PERSONAL HEARING SCREENER
Applicant
BELTONE ELECTRONICS CORP.
4201 WEST VICTORIA ST.
CHICAGO,  IL  60646
Applicant Contact ROBERT A KRATOCHVIL
Correspondent
BELTONE ELECTRONICS CORP.
4201 WEST VICTORIA ST.
CHICAGO,  IL  60646
Correspondent Contact ROBERT A KRATOCHVIL
Regulation Number874.1050
Classification Product Code
EWO  
Date Received07/27/1994
Decision Date 07/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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