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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Self-Fitting Air-Conduction Hearing Aid, Over The Counter
510(k) Number K221052
Device Name Self-Fitting hearing aids
Applicant
Huizhou Jinghao Medical Technology Co., Ltd.
Floor 6, Huicheng Industry Bldg.,
#9 Huifeng Dong'Er Rd. Zhongkai High-Tech Zone
Huizhou,  CN 516006
Applicant Contact Yuanxia Mao
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co.Ltd
Rm. 1407, Jingting Bldg., Dongzhou Community, Guangming
St., Guangming District
Shenzhen,  CN 518000
Correspondent Contact Reanny Wang
Regulation Number874.3325
Classification Product Code
QUH  
Date Received04/11/2022
Decision Date 09/25/2023
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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