Clearance Summary
OPTEC 2300 AFVT, ARMED FORCES VISION TESTER received FDA 510(k) clearance under submission number K904828, sponsored by Stereo Optical Co., 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 1991-01-18.
- Submission: K904828
- Applicant / Sponsor: Stereo Optical Co., Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1760
- Decision date: 1991-01-18
Classification & Regulation
This clearance is catalogued under FDA product code HKO and 21 CFR 886.1760, within the Ophthalmic review panel as a Class I device.