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510(k) K922242

910T MONTORIZED INSTRUMENT TABLE by R.H. Burton Co. — Product Code HRJ

K922242 is an FDA 510(k) premarket notification submitted by R.H. Burton Co. for the device "910T MONTORIZED INSTRUMENT TABLE". The FDA issued a decision of Substantially Equivalent on September 30, 1992. The device falls under product code HRJ (Table, Instrument, Powered, Ophthalmic), a Class I device regulated under 21 CFR 886.4855. R.H. Burton Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1992
Date Received
May 13, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Instrument, Powered, Ophthalmic
Device Class
Class I
Regulation Number
886.4855
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)
  • K924785 — BURTON RADIUSGAUGE - MODEL 2030 (April 5, 1993)
  • K924777 — BURTON APPLANATION TONOMETER - MODEL T850 & T1000 (April 5, 1993)

Other clearances for product code HRJ

  • K930447 — MARCO H AND TS-1 INSTRUMENT TABLES (July 6, 1993)
  • K912134 — TBD, LENS MEASURING DEVICE (July 25, 1991)
  • K853744 — TECHNA VISION, INC.ELECTRIC TABLE (October 17, 1985)
  • K853359 — RELIANCE 1379 (September 24, 1985)
  • K841760 — WOODLYN CLASSIC INSTRUMENT STAND (June 19, 1984)
  • K833820 — MACHEMER/TANO ROTATING (January 4, 1984)

FDA data resources