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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nystagmograph
510(k) Number K163149
Device Name VisualEyes
Applicant
Interacoustics A/S
Audiometer Alle 1
Middelfart,  DK 5500
Applicant Contact Erik Nielsen
Correspondent
Interacoustics A/S
Audiometer Alle 1
Middelfart,  DK 5500
Correspondent Contact Erik Nielsen
Regulation Number882.1460
Classification Product Code
GWN  
Date Received11/09/2016
Decision Date 04/26/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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