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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 K141524
Device Name NEURO-AUDIO
Applicant
Teleemg, LLC USA
88 Stiles Rd.
Salem,  NH  03079
Applicant Contact BARRY ASHAR
Correspondent
Teleemg, LLC USA
88 Stiles Rd.
Salem,  NH  03079
Correspondent Contact BARRY ASHAR
Regulation Number874.1050
Classification Product Code
EWO  
Subsequent Product Code
GWJ  
Date Received06/09/2014
Decision Date 03/12/2015
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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