Clearance Summary
Hushd Pro Avera received FDA 510(k) clearance under submission number K232025, sponsored by Good Sleep CO Pte , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2024-05-09.
- Submission: K232025
- Applicant / Sponsor: Good Sleep CO Pte , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2024-05-09
Classification & Regulation
This clearance is catalogued under FDA product code LRK and 21 CFR 872.5570, within the Dental review panel as a Class II device.