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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Auditory Impedance
510(k) Number K845049
Device Name Z0174, IMPEDANCE AUDIOMETER
Applicant
Madsen Electronics (Canada) , Ltd.
2370 Speers Rd.
P.O. Box 535
Oakville, Ontario,  CA L6J5B4
Applicant Contact DAVID E ABRAHAM
Correspondent
Madsen Electronics (Canada) , Ltd.
2370 Speers Rd.
P.O. Box 535
Oakville, Ontario,  CA L6J5B4
Correspondent Contact DAVID E ABRAHAM
Regulation Number874.1090
Classification Product Code
ETY  
Date Received11/26/1984
Decision Date 05/21/1985
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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