Clearance Summary
RETINAL FUNCTIONAL IMAGER (RFI) received FDA 510(k) clearance under submission number K062416, sponsored by Optical Imaging , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2006-11-17.
- Submission: K062416
- Applicant / Sponsor: Optical Imaging , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1120
- Decision date: 2006-11-17
Classification & Regulation
This clearance is catalogued under FDA product code HKI and 21 CFR 886.1120, within the Ophthalmic review panel as a Class II device.