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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 K994254
Device Name INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER
Applicant
International Distributors of Electronics For Medi
4814 E. Second St.
Benicia,  CA  94510
Applicant Contact DONNA WARD
Correspondent
International Distributors of Electronics For Medi
4814 E. Second St.
Benicia,  CA  94510
Correspondent Contact DONNA WARD
Regulation Number874.1090
Classification Product Code
ETY  
Date Received12/17/1999
Decision Date 03/14/2000
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
Predetermined Change
Control Plan Authorized		 No
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