Clearance Summary
ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540 received FDA 510(k) clearance under submission number K871611, sponsored by Allergan Humphrey. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1987-05-18.
- Submission: K871611
- Applicant / Sponsor: Allergan Humphrey
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1760
- Decision date: 1987-05-18
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.