Clearance Summary
HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN received FDA 510(k) clearance under submission number K864467, sponsored by Keeler 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 1986-12-15.
- Submission: K864467
- Applicant / Sponsor: Keeler Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1605
- Decision date: 1986-12-15
Classification & Regulation
This clearance is catalogued under FDA product code HOO and 21 CFR 886.1605, within the Ophthalmic review panel as a Class I device.