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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 K904622
Device Name HEARING CHECKER(TM), DESKTOP MODEL
Applicant
QUALITONE HEARING AIDS AND AUDIOMETERS
4931 W. 35TH ST.
MINNEAPOLIS,  MN  55416
Applicant Contact BRUCE A BROWN
Correspondent
QUALITONE HEARING AIDS AND AUDIOMETERS
4931 W. 35TH ST.
MINNEAPOLIS,  MN  55416
Correspondent Contact BRUCE A BROWN
Regulation Number874.1050
Classification Product Code
EWO  
Date Received10/11/1990
Decision Date 09/17/1991
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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