Clearance Summary
CARBON DIOXIDE & OXYGEN MONITOR TYPE 1308 received FDA 510(k) clearance under submission number K925484, sponsored by Bruel & Kjaer. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1993-06-22.
- Submission: K925484
- Applicant / Sponsor: Bruel & Kjaer
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 1993-06-22
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.