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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 K983051
Device Name AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
Applicant
AMERICAN ELECTROMEDICS CORP.
P.O. BOX 9169
CHICO,  CA  95927
Applicant Contact FRANK FERGUSON
Correspondent
AMERICAN ELECTROMEDICS CORP.
P.O. BOX 9169
CHICO,  CA  95927
Correspondent Contact FRANK FERGUSON
Regulation Number874.1090
Classification Product Code
ETY  
Subsequent Product Code
EWO  
Date Received09/01/1998
Decision Date 11/18/1998
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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