Clearance Summary
TRI-MED 610 CAPNOSTAT GAS ANALYZER received FDA 510(k) clearance under submission number K843285, sponsored by Tri-Med, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1984-11-13.
- Submission: K843285
- Applicant / Sponsor: Tri-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 1984-11-13
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.