Clearance Summary
CENTRAL VISION ANALYZER MODEL 1000 received FDA 510(k) clearance under submission number K100095, sponsored by Vimetrics,Llc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2010-05-10.
- Submission: K100095
- Applicant / Sponsor: Vimetrics,Llc.
- Clearance pathway: Abbreviated
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1150
- Decision date: 2010-05-10
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.