Clearance Summary
NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES received FDA 510(k) clearance under submission number K990063, sponsored by Nihon Kohden America, 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 1999-06-09.
- Submission: K990063
- Applicant / Sponsor: Nihon Kohden America, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 1999-06-09
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.