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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 K200534
Device Name VisualEyes
Applicant
Interacoustics A/S
Audiometer Alle 1
Middelfart,  DK 5500
Applicant Contact Erik Nielson
Correspondent
Interacoustics A/S
Audiometer Alle 1
Middelfart,  DK 5500
Correspondent Contact Erik Nielson
Regulation Number882.1460
Classification Product Code
GWN  
Date Received03/02/2020
Decision Date 08/12/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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