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510(k) K924777

BURTON APPLANATION TONOMETER - MODEL T850 & T1000 by R.H. Burton Co. — Product Code HKX

K924777 is an FDA 510(k) premarket notification submitted by R.H. Burton Co. for the device "BURTON APPLANATION TONOMETER - MODEL T850 & T1000". The FDA issued a decision of Substantially Equivalent on April 5, 1993. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930. 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
Tonometer, Ac-Powered
Device Class
Class II
Regulation Number
886.1930
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 HKX

  • K253039 — AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA (November 7, 2025)
  • K223739 — VS Tabletop Tonometer (November 8, 2023)
  • K190382 — Intraocular Pressure Tonometer EASYTON (December 6, 2019)
  • K181260 — MiiS Horus Scope DPT 100 (June 21, 2019)
  • K181143 — Keeler TonoCare Tonometer (February 8, 2019)
  • K180820 — Tono Vue Non-Contact Tonometer (December 14, 2018)
  • K162067 — VX130 Ophthalmic Diagnostic Device (April 24, 2017)
  • K143086 — VX120 Ophthalmic Diagnostic Device (June 1, 2015)
  • K113066 — CORVIS ST (November 8, 2012)
  • K111710 — FULL AUTO TONOMETER MODEL TX-20 (September 20, 2011)

FDA data resources