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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 K173567
Device Name Sera
Applicant
Interacoustics A/S
Audiometer Alle 1
Middelfart,  DK 5500
Applicant Contact Amy Yanta
Correspondent
Interacoustics A/S
Audiometer Alle 1
Middelfart,  DK 5500
Correspondent Contact Amy Yanta
Regulation Number874.1050
Classification Product Code
EWO  
Subsequent Product Code
GWJ  
Date Received11/20/2017
Decision Date 02/14/2018
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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