FDA 510(k) Application Details - K221052

Device Classification Name	More FDA Info for this Device
510(K) Number	K221052
Device Name	Self-Fitting hearing aids
Applicant	Huizhou Jinghao Medical Technology Co., Ltd. Floor 6, Huicheng Industry Building, No.9 Huifeng Dong'er Road Zhongkai High-Tech Zone Huizhou 516006 CN Other 510(k) Applications for this Company
Contact	Yuanxia Mao Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2022
Decision Date	09/25/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review