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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 K983851
Device Name CAPELLA COCHLEAR EMISSIONS ANALYZER
Applicant
MADSEN ELECTRONICS, INC.
5600 ROWLAND RD.
MINNETONKA,  MN  55343
Applicant Contact TRACY MILLIER
Correspondent
MADSEN ELECTRONICS, INC.
5600 ROWLAND RD.
MINNETONKA,  MN  55343
Correspondent Contact TRACY MILLIER
Regulation Number874.1050
Classification Product Code
EWO  
Date Received10/30/1998
Decision Date 01/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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