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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 K112733
Device Name ER35 ERO-SCAN PRO HEARING TEST SYSTEM
Applicant
Etymotic Research, Inc.
2001 Pennsylvania Ave. NW, Suite 950
Washington,  DC  20006
Applicant Contact JACK KENT
Correspondent
Etymotic Research, Inc.
2001 Pennsylvania Ave. NW, Suite 950
Washington,  DC  20006
Correspondent Contact JACK KENT
Regulation Number874.1050
Classification Product Code
EWO  
Subsequent Product Code
ETY  
Date Received09/20/2011
Decision Date 12/16/2011
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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