FDA 510(k) Application Details - K223137

Device Classification Name	More FDA Info for this Device
510(K) Number	K223137
Device Name	Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application
Applicant	hearX SA (Pty) Ltd. Building 2, Ashlea Gardens Office Park, 180 Garsfontein Road, Ashlea Gardens Pretoria 0081 ZA Other 510(k) Applications for this Company
Contact	Seline Van Der Wat 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	10/04/2022
Decision Date	03/14/2023
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