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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Air-Conduction Hearing Aid Software
510(k) Number K261187
Device Name Hearing Aid Feature
Applicant
Samsung Electronics Co., Ltd.
129 Samsung-Ro, Yeoungton-Gu
Suwon-Si,  KR
Applicant Contact Hon Pak
Correspondent
Samsung Research America, Inc.
665 Clyde Ave.
Mountain View,  CA  94043
Correspondent Contact Chaoyi Kang
Classification Product Code
SCR  
Date Received04/10/2026
Decision Date 07/31/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT07020663
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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