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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
Predetermined Change
Control Plan Authorized		 No
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