Clearance Summary
MAC-LINE CO2 NASAL CANNULA SAMPLE LINE received FDA 510(k) clearance under submission number K012391, sponsored by Oridion Medical 1987 , 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 2001-08-15.
- Submission: K012391
- Applicant / Sponsor: Oridion Medical 1987 , Ltd.
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 2001-08-15
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.