Clearance Summary
NIC OPTRONICS CS-2000 received FDA 510(k) clearance under submission number K822215, sponsored by Nicolet Biomedical Instruments. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1982-08-31.
- Submission: K822215
- Applicant / Sponsor: Nicolet Biomedical Instruments
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1150
- Decision date: 1982-08-31
Classification & Regulation
This clearance is catalogued under FDA product code HOX and 21 CFR 886.1150, within the Ophthalmic review panel as a Class I device.