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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 K951527
Device Name THE PILOT AUDIOMETER
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 Number874.1050
Classification Product Code
EWO  
Date Received04/03/1995
Decision Date 05/03/1995
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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