Clearance Summary
TONO-PEN TONOMETER TIP COVER received FDA 510(k) clearance under submission number K033146, sponsored by Tra & Accessories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2004-11-23.
- Submission: K033146
- Applicant / Sponsor: Tra & Accessories
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1930
- Decision date: 2004-11-23
Classification & Regulation
This clearance is catalogued under FDA product code HKY and 21 CFR 886.1930, within the Ophthalmic review panel as a Class II device.