Home / 510(k) Clearances / K924779

510(k) K924779

BURTON KERATOMETER - MODLE 2040 by R.H. Burton Co. — Product Code HJB

K924779 is an FDA 510(k) premarket notification submitted by R.H. Burton Co. for the device "BURTON KERATOMETER - MODLE 2040". The FDA issued a decision of Substantially Equivalent on April 5, 1993. The device falls under product code HJB (Instrument, Measuring, Corneal Radius), a Class I device regulated under 21 CFR 886.1450. R.H. Burton Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1993
Date Received
September 23, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Measuring, Corneal Radius
Device Class
Class I
Regulation Number
886.1450
Review Panel
OP
Submission Type

Other clearances by R.H. Burton Co.

  • K924773 — BURTON H- BASE TABLE - MODEL 1990 (June 7, 1993)
  • K924786 — BURTON TRIAL LENS SET (April 14, 1993)
  • K924774 — BURTON AUTOMATIC PROJECTOR - MODEL CP-40 (April 14, 1993)
  • K924783 — BURTON SLIT LAMP - MODEL 850 (April 14, 1993)
  • K924788 — BURTON LENSMETER (April 5, 1993)
  • K924790 — BURTON AUTO REFRACTOR - MODEL BAR-7 (April 5, 1993)
  • K924778 — BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8 (April 5, 1993)
  • K924771 — BURTON OPHTHALMIC STAND - MODEL XL3200 (April 5, 1993)
  • K924784 — BURTON PROJECTOR HEAD - MODEL 6000-H (April 5, 1993)
  • K924776 — BURTON LENSMETER - MODEL 2021 (April 5, 1993)

Other clearances for product code HJB

  • K930444 — MARCO STANDARD KERATOMETERS (August 9, 1993)
  • K864369 — LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER (December 15, 1986)
  • K864037 — KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER (November 13, 1986)
  • K852424 — ACUFEX COMPARATIVE SURGICAL KERATOMETER (September 11, 1985)

FDA data resources