Clearance Summary
DIGILAB MODULAR ONE-APPLANATION TONOMETER received FDA 510(k) clearance under submission number K863217, sponsored by Bio-Rad. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1986-09-24.
- Submission: K863217
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1930
- Decision date: 1986-09-24
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.