Clearance Summary
TG-970P CO2 Sensor Kit received FDA 510(k) clearance under submission number K161860, sponsored by Nihon Kohden Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2017-02-24.
- Submission: K161860
- Applicant / Sponsor: Nihon Kohden Corporation
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 2017-02-24
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.