Clearance Summary
RTA RETINAL THICKNESS ANALYZER received FDA 510(k) clearance under submission number K964137, sponsored by Talia Technology , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1997-02-03.
- Submission: K964137
- Applicant / Sponsor: Talia Technology , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1570
- Decision date: 1997-02-03
Classification & Regulation
This clearance is catalogued under FDA product code HLI and 21 CFR 886.1570, within the Ophthalmic review panel as a Class II device.