Clearance Summary
MODEL 5400 OPTOKINETIC STIMULATOR received FDA 510(k) clearance under submission number K822917, sponsored by Life-Tech Intl., 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 1982-11-01.
- Submission: K822917
- Applicant / Sponsor: Life-Tech Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1200
- Decision date: 1982-11-01
Classification & Regulation
This clearance is catalogued under FDA product code HOW and 21 CFR 886.1200, within the Ophthalmic review panel as a Class I device.