Clearance Summary
F4912 NIGHT VISION AID received FDA 510(k) clearance under submission number K761215, sponsored by Itt Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1976-12-16.
- Submission: K761215
- Applicant / Sponsor: Itt Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5900
- Decision date: 1976-12-16
Classification & Regulation
This clearance is catalogued under FDA product code HPG and 21 CFR 886.5900, within the Ophthalmic review panel as a Class I device.