Clearance Summary
AG100s received FDA 510(k) clearance under submission number K221477, sponsored by Hospitech Respiration , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2022-12-29.
- Submission: K221477
- Applicant / Sponsor: Hospitech Respiration , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5750
- Decision date: 2022-12-29
Classification & Regulation
This clearance is catalogued under FDA product code BSK and 21 CFR 868.5750, within the Anesthesiology review panel as a Class II device.