Clearance Summary
GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS received FDA 510(k) clearance under submission number K110594, sponsored by Nihon Kohden Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2011-10-28.
- Submission: K110594
- Applicant / Sponsor: Nihon Kohden Corp.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 2011-10-28
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.