FDA 510(k) Application Details - K233464

Device Classification Name	More FDA Info for this Device
510(K) Number	K233464
Device Name	WSA Self-Fitting Hearing Aid Gen 2
Applicant	WSAUD A/S Nym°llevej 6 Lynge 13540 DK Other 510(k) Applications for this Company
Contact	La-Shaunda Joseph 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	10/23/2023
Decision Date	02/09/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review