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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 K874354
Device Name AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020
Applicant
MADSEN ELECTRONICS (CANADA) LTD.
2370 SPEERS ROAD
P.O. BOX 535
OAKVILLE, ONTARIO,  CA L6J5B4
Applicant Contact ZOILA FLORES
Correspondent
MADSEN ELECTRONICS (CANADA) LTD.
2370 SPEERS ROAD
P.O. BOX 535
OAKVILLE, ONTARIO,  CA L6J5B4
Correspondent Contact ZOILA FLORES
Regulation Number874.1090
Classification Product Code
ETY  
Date Received10/23/1987
Decision Date 01/27/1988
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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