FDA 510(k) Application Details - K231545

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K231545
Device Name	Audiometer
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	874.1050   More FDA Info for this Regulation Number
Classification Product Code	EWO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/2023
Decision Date	10/27/2023
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