FDA 510(k) Application Details - DEN230081

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230081
Device Name	Hearing Aid Feature (HAF)
Applicant	Apple Inc. One Apple Park Way Cupertino, CA 95014 US Other 510(k) Applications for this Company
Contact	Kevin Go 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	12/04/2023
Decision Date	09/12/2024
Decision	DENG -
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review