Clearance Summary
CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style received FDA 510(k) clearance under submission number K143127, sponsored by Dispo-Med (Malaysia) Sdn Bhd. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2015-02-13.
- Submission: K143127
- Applicant / Sponsor: Dispo-Med (Malaysia) Sdn Bhd
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 2015-02-13
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.