Clearance Summary
FIXATION MONITOR received FDA 510(k) clearance under submission number K822601, sponsored by West Coast Optical Instruments, 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 1982-09-30.
- Submission: K822601
- Applicant / Sponsor: West Coast Optical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1605
- Decision date: 1982-09-30
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.