Clearance Summary
TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER received FDA 510(k) clearance under submission number K053430, sponsored by Medtronic Xomed, 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 2006-03-03.
- Submission: K053430
- Applicant / Sponsor: Medtronic Xomed, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1930
- Decision date: 2006-03-03
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.