Clearance Summary
MACULAR FUNCTION ANALYZER received FDA 510(k) clearance under submission number K843227, sponsored by Danek Medical, 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 1985-07-22.
- Submission: K843227
- Applicant / Sponsor: Danek Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1330
- Decision date: 1985-07-22
Classification & Regulation
This clearance is catalogued under FDA product code HOQ and 21 CFR 886.1330, within the Ophthalmic review panel as a Class I device.