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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 K990652
Device Name INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER
Applicant
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)
4814 EAST SECOND ST.
BENICIA,  CA  94510
Applicant Contact DONNA WARD
Correspondent
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)
4814 EAST SECOND ST.
BENICIA,  CA  94510
Correspondent Contact DONNA WARD
Regulation Number874.1090
Classification Product Code
ETY  
Subsequent Product Code
EWO  
Date Received03/01/1999
Decision Date 05/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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