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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 K955289
Device Name RACE CAR TYMPANOMETER
Applicant
American Electromedics Corp.
13 Columbus Dr.
Suite 18
Amherst,  NH  03031
Applicant Contact NOEL A WREN
Correspondent
American Electromedics Corp.
13 Columbus Dr.
Suite 18
Amherst,  NH  03031
Correspondent Contact NOEL A WREN
Regulation Number874.1090
Classification Product Code
ETY  
Date Received11/16/1995
Decision Date 12/08/1995
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
Predetermined Change
Control Plan Authorized		 No
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