Clearance Summary
NIDEK DIGITAL KERATOMETER received FDA 510(k) clearance under submission number K842892, sponsored by Nidek, 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 1984-10-05.
- Submission: K842892
- Applicant / Sponsor: Nidek, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class III
- Regulation citation: 21 CFR 886.3600
- Decision date: 1984-10-05
Classification & Regulation
This clearance is catalogued under FDA product code HQL and 21 CFR 886.3600, within the Ophthalmic review panel as a Class III device.