Clearance Summary
DIGITAL AVERAGING TONOMETER received FDA 510(k) clearance under submission number K945972, sponsored by Opti-Med Electronics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1995-08-17.
- Submission: K945972
- Applicant / Sponsor: Opti-Med Electronics
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1930
- Decision date: 1995-08-17
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.