Clearance Summary
EAGLE EYES received FDA 510(k) clearance under submission number K964366, sponsored by Mech-Tronic Precision Mfg., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1997-01-29.
- Submission: K964366
- Applicant / Sponsor: Mech-Tronic Precision Mfg., Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5850
- Decision date: 1997-01-29
Classification & Regulation
This clearance is catalogued under FDA product code HQY and 21 CFR 886.5850, within the Ophthalmic review panel as a Class I device.