Clearance Summary
PRE-CHECK C02 DETECTOR received FDA 510(k) clearance under submission number K861398, sponsored by Alleghany Intl. Medical Technology. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1986-05-06.
- Submission: K861398
- Applicant / Sponsor: Alleghany Intl. Medical Technology
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 1986-05-06
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.