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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 K942716
Device Name AUDIO EXPERT AUDIOMETER
Applicant
Beltone Electronics Corp.
4201 W. Victoria St.
Chicago,  IL  60646
Applicant Contact ROBERT A KRATOCHVIL
Correspondent
Beltone Electronics Corp.
4201 W. Victoria St.
Chicago,  IL  60646
Correspondent Contact ROBERT A KRATOCHVIL
Regulation Number874.1050
Classification Product Code
EWO  
Subsequent Product Code
KHL  
Date Received06/09/1994
Decision Date 09/02/1994
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
Predetermined Change
Control Plan Authorized		 No
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