FDA 510(k) Application Details - K243150

Device Classification Name	More FDA Info for this Device
510(K) Number	K243150
Device Name	Nuance Audio Hearing Aid Software
Applicant	Luxottica Group S.P.A. Piazzale Cadorna 3 Milan 20123 IT Other 510(k) Applications for this Company
Contact	Giulia Cuccato Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SCR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2024
Decision Date	01/31/2025
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