Clearance Summary
CANON FULL AUTO TONOMETER TX-F received FDA 510(k) clearance under submission number K023816, sponsored by Canon, Inc.-Utsunomiya Optical Products Operation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2002-11-26.
- Submission: K023816
- Applicant / Sponsor: Canon, Inc.-Utsunomiya Optical Products Operation
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1930
- Decision date: 2002-11-26
Classification & Regulation
This clearance is catalogued under FDA product code HKX and 21 CFR 886.1930, within the Ophthalmic review panel as a Class II device.