Clearance Summary
POLARIS 2004 CAPNOGRAPH received FDA 510(k) clearance under submission number K040011, sponsored by Oridion , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2004-05-13.
- Submission: K040011
- Applicant / Sponsor: Oridion , Ltd.
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 2004-05-13
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.