Clearance Summary
Sonu received FDA 510(k) clearance under submission number K242214, sponsored by Sound Health Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2025-04-24.
- Submission: K242214
- Applicant / Sponsor: Sound Health Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.6010
- Decision date: 2025-04-24
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.