Clearance Summary
INFINITY MCABLE - MAINSTREAM CO2 received FDA 510(k) clearance under submission number K100941, sponsored by Draeger Medical AG & Co. KG. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2010-04-23.
- Submission: K100941
- Applicant / Sponsor: Draeger Medical AG & Co. KG
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 2010-04-23
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.