Clearance Summary
BURTON OPHTHALMIC EXAM UNIT - MODEL 2201 received FDA 510(k) clearance under submission number K924780, sponsored by R.H. Burton Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1993-04-05.
- Submission: K924780
- Applicant / Sponsor: R.H. Burton Co.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1860
- Decision date: 1993-04-05
Classification & Regulation
This clearance is catalogued under FDA product code HMF and 21 CFR 886.1860, within the Ophthalmic review panel as a Class I device.