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510(k) K924771

BURTON OPHTHALMIC STAND - MODEL XL3200 by R.H. Burton Co. — Product Code HMF

K924771 is an FDA 510(k) premarket notification submitted by R.H. Burton Co. for the device "BURTON OPHTHALMIC STAND - MODEL XL3200". The FDA issued a decision of Substantially Equivalent on April 5, 1993. The device falls under product code HMF (Stand, Instrument, Ac-Powered, Ophthalmic), a Class I device regulated under 21 CFR 886.1860. 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
Stand, Instrument, Ac-Powered, Ophthalmic
Device Class
Class I
Regulation Number
886.1860
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)
  • K924776 — BURTON LENSMETER - MODEL 2021 (April 5, 1993)
  • K924785 — BURTON RADIUSGAUGE - MODEL 2030 (April 5, 1993)
  • K924777 — BURTON APPLANATION TONOMETER - MODEL T850 & T1000 (April 5, 1993)

Other clearances for product code HMF

  • K935952 — ROTA SYSTEM 5000 (April 19, 1994)
  • K935945 — ROTA DATAMATE I (April 19, 1994)
  • K931839 — ROTA SYSTEM XL (November 22, 1993)
  • K930440 — MARCO INTERNATIONAL STAND (July 6, 1993)
  • K924780 — BURTON OPHTHALMIC EXAM UNIT - MODEL 2201 (April 5, 1993)
  • K913961 — OPHTHALMIC STAND (December 4, 1991)
  • K853358 — RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM (October 4, 1985)
  • K844362 — OPHTHALMIC CHAIR (December 11, 1984)
  • K844363 — OPHTHALMIC STAND (December 5, 1984)
  • K832073 — ELECTRIC INSTRUMENT TABLE (August 12, 1983)

FDA data resources