meddevicedb.com FDA Device Reference

Hearing Aid Feature (HAF)

DEN230081 Class II Direct
Decision Date
2024-09-12
Sponsor / Applicant
Apple, Inc.

Technical Specification

510(k) Submission ID DEN230081
Product Code SCR
Medical Specialty / Panel Ear, Nose, Throat
Regulation Citation 21 CFR 874.3335
Decision Date 2024-09-12
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Hearing Aid Feature (HAF) received FDA 510(k) clearance under submission number DEN230081, sponsored by Apple, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2024-09-12.

Classification & Regulation

This clearance is catalogued under FDA product code SCR and 21 CFR 874.3335, within the Ear, Nose, Throat review panel as a Class II device.