Clearance Summary
IN-HOME VISION MONITORING KIT received FDA 510(k) clearance under submission number K854047, sponsored by Rich-Larky Company, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1985-12-13.
- Submission: K854047
- Applicant / Sponsor: Rich-Larky Company, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1150
- Decision date: 1985-12-13
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.