Clearance Summary
CO2 Mainstream Module received FDA 510(k) clearance under submission number K192446, sponsored by Beijing Kingst Commercial & Trade Co., 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 2020-05-21.
- Submission: K192446
- Applicant / Sponsor: Beijing Kingst Commercial & Trade Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 2020-05-21
Classification & Regulation
This clearance is catalogued under FDA product code CCK and 21 CFR 868.1400, within the Anesthesiology review panel as a Class II device.