Clearance Summary
CO2 Mainstream Sensor received FDA 510(k) clearance under submission number K221118, sponsored by Draegerwerk AG & CO Kgaa. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2023-04-05.
- Submission: K221118
- Applicant / Sponsor: Draegerwerk AG & CO Kgaa
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 2023-04-05
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.