Clearance Summary
HUMPHREY FIELD ANALYZER (HFA II) received FDA 510(k) clearance under submission number K954167, sponsored by Carl Zeiss, 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 1995-11-24.
- Submission: K954167
- Applicant / Sponsor: Carl Zeiss, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1605
- Decision date: 1995-11-24
Classification & Regulation
This clearance is catalogued under FDA product code HPT and 21 CFR 886.1605, within the Ophthalmic review panel as a Class I device.