Clearance Summary
GENERATED RETINAL REFLEX IMAGERY SYS received FDA 510(k) clearance under submission number K840840, sponsored by Electro Optical 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 1984-07-12.
- Submission: K840840
- Applicant / Sponsor: Electro Optical Instruments
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1780
- Decision date: 1984-07-12
Classification & Regulation
This clearance is catalogued under FDA product code HKM and 21 CFR 886.1780, within the Ophthalmic review panel as a Class I device.