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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 K981327
Device Name INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER
Applicant
Idem (Int'L Dist. of Electronics For Medicine)
4814 E. Second St.
Benicia,  CA  94510
Applicant Contact DONNA WARD
Correspondent
Idem (Int'L Dist. of Electronics For Medicine)
4814 E. Second St.
Benicia,  CA  94510
Correspondent Contact DONNA WARD
Regulation Number874.1050
Classification Product Code
EWO  
Date Received04/13/1998
Decision Date 05/11/1998
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
Predetermined Change
Control Plan Authorized		 No
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