Clearance Summary
MARK 5 NUVO LITE OCSI AND STD received FDA 510(k) clearance under submission number K082566, sponsored by Nidek Medical Products, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2008-12-03.
- Submission: K082566
- Applicant / Sponsor: Nidek Medical Products, Inc.
- Clearance pathway: Abbreviated
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 2008-12-03
Classification & Regulation
This clearance is catalogued under FDA product code CAW and 21 CFR 868.5440, within the Anesthesiology review panel as a Class II device.