Clearance Summary
FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440 received FDA 510(k) clearance under submission number K093071, sponsored by Fundus Photo, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2010-11-17.
- Submission: K093071
- Applicant / Sponsor: Fundus Photo, LLC
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1120
- Decision date: 2010-11-17
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.