Clearance Summary
FULL AUTO TONOMETER MODEL TX-20 received FDA 510(k) clearance under submission number K111710, sponsored by Canon Inc. -Medical Equipment Group. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2011-09-20.
- Submission: K111710
- Applicant / Sponsor: Canon Inc. -Medical Equipment Group
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1930
- Decision date: 2011-09-20
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.