Clearance Summary
RADx Intraoral Appliance for Snoring and Sleep Apnea received FDA 510(k) clearance under submission number K230532, sponsored by Achaemenid, LLC. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2023-07-12.
- Submission: K230532
- Applicant / Sponsor: Achaemenid, LLC
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2023-07-12
Classification & Regulation
This clearance is catalogued under FDA product code LQZ and 21 CFR 872.5570, within the Dental review panel as a Class II device.