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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 K883478
Device Name DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602
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 Number874.1050
Classification Product Code
EWO  
Date Received08/16/1988
Decision Date 11/17/1988
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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