Clearance Summary
MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD received FDA 510(k) clearance under submission number K123738, sponsored by Nidek Medical Products, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2013-02-28.
- Submission: K123738
- Applicant / Sponsor: Nidek Medical Products, Inc.
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 2013-02-28
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.