Clearance Summary
Onera Sleep Test System (Onera STS) received FDA 510(k) clearance under submission number K223573, sponsored by Onera B.V.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2023-08-18.
- Submission: K223573
- Applicant / Sponsor: Onera B.V.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.2375
- Decision date: 2023-08-18
Classification & Regulation
This clearance is catalogued under FDA product code MNR and 21 CFR 868.2375, within the Anesthesiology review panel as a Class II device.