Clearance Summary
KASHA VISUAL FIELD SYSTEM received FDA 510(k) clearance under submission number K971156, sponsored by Kasha Software, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1997-05-28.
- Submission: K971156
- Applicant / Sponsor: Kasha Software, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1605
- Decision date: 1997-05-28
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.