meddevicedb.com FDA Device Reference

Sonu

DEN230045 Class II Direct
Decision Date
2023-12-04
Sponsor / Applicant
Sound Health Systems, Inc.

Technical Specification

510(k) Submission ID DEN230045
Product Code QZC
Medical Specialty / Panel Ear, Nose, Throat
Regulation Citation 21 CFR 874.6010
Decision Date 2023-12-04
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

Sonu received FDA 510(k) clearance under submission number DEN230045, sponsored by Sound Health Systems, 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 2023-12-04.

Classification & Regulation

This clearance is catalogued under FDA product code QZC and 21 CFR 874.6010, within the Ear, Nose, Throat review panel as a Class II device.