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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 K931325
Device Name OTOACOUSTIC EMISSIONS UNIT CELESTA 503
Applicant
MADSEN ELECTRONICS (CANADA) LTD.
5600 ROWLAND RD.
MINNETONKA,  MN  55343
Applicant Contact MARSHALL ROSNER
Correspondent
MADSEN ELECTRONICS (CANADA) LTD.
5600 ROWLAND RD.
MINNETONKA,  MN  55343
Correspondent Contact MARSHALL ROSNER
Regulation Number874.1050
Classification Product Code
EWO  
Date Received03/16/1993
Decision Date 02/18/1994
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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