Clearance Summary
DIGITAL RETINOSCOPIC PHOTOMETER received FDA 510(k) clearance under submission number K951179, sponsored by Kudi Kalu, 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 1995-05-30.
- Submission: K951179
- Applicant / Sponsor: Kudi Kalu, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1760
- Decision date: 1995-05-30
Classification & Regulation
This clearance is catalogued under FDA product code HKO and 21 CFR 886.1760, within the Ophthalmic review panel as a Class I device.