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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 K935348
Device Name ODYSSEY CLINICAL AUDIOMETER
Applicant
QUALITONE
4931 WEST 35TH ST.
MINNEAPOLIS,  MN  55416
Applicant Contact BRUCE BROWN
Correspondent
QUALITONE
4931 WEST 35TH ST.
MINNEAPOLIS,  MN  55416
Correspondent Contact BRUCE BROWN
Regulation Number874.1050
Classification Product Code
EWO  
Date Received11/05/1993
Decision Date 02/09/1994
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
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