FDA 510(k) Application Details - K230538

Device Classification Name	More FDA Info for this Device
510(K) Number	K230538
Device Name	All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid
Applicant	Sonova AG Laubisruetistrasse 28 Zurich 8712 CH Other 510(k) Applications for this Company
Contact	Nelson Hu 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	02/27/2023
Decision Date	06/16/2023
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