Clearance Summary
DOT VISUAL ACVITY TEST 2000 received FDA 510(k) clearance under submission number K833956, sponsored by Good-Lite Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1984-01-04.
- Submission: K833956
- Applicant / Sponsor: Good-Lite Co.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1150
- Decision date: 1984-01-04
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.