Clearance Summary
BAYLOR VISUAL FIELDS PROGRAMMER received FDA 510(k) clearance under submission number K791295, sponsored by Schiff Harding Waite. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1979-08-10.
- Submission: K791295
- Applicant / Sponsor: Schiff Harding Waite
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1605
- Decision date: 1979-08-10
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.