Clearance Summary
TRUEFIELD ANALYZER received FDA 510(k) clearance under submission number K063310, sponsored by Seeing Machines Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2007-08-02.
- Submission: K063310
- Applicant / Sponsor: Seeing Machines Limited
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1605
- Decision date: 2007-08-02
Classification & Regulation
This clearance is catalogued under FDA product code HPT and 21 CFR 886.1605, within the Ophthalmic review panel as a Class I device.