FDA 510(k) Application Details - K232999

Device Classification Name	Hearing Aid, Air Conduction   More FDA Info for this Device
510(K) Number	K232999
Device Name	Hearing Aid, Air Conduction
Applicant	Sonova AG 28 Laubisruetistrasse Staefa 8712 CH Other 510(k) Applications for this Company
Contact	Kateryna Konovalenko Other 510(k) Applications for this Contact
Regulation Number	874.3300   More FDA Info for this Regulation Number
Classification Product Code	ESD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/22/2023
Decision Date	04/11/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review