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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 K243709
Device Name NeuroEars-Anna™
Applicant
Neuroears, Inc.
7, Huseok-Ro 462beon-Gil
Chuncheon-Si
Gangwon-Do,  KR
Applicant Contact Suh Kyoowon
Correspondent
Empirical Technologies
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Hannah Taggart
Regulation Number882.1460
Classification Product Code
GWN  
Date Received12/02/2024
Decision Date 08/25/2025
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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