Clearance Summary
CARBOSTAT, CO2 ANALYZER received FDA 510(k) clearance under submission number K862559, sponsored by Elm Street Designs. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1986-07-15.
- Submission: K862559
- Applicant / Sponsor: Elm Street Designs
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 1986-07-15
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.