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510(k) K853290

TECHNA VISION AUTO-PERIMETER by Techna Vision — Product Code HPT

K853290 is an FDA 510(k) premarket notification submitted by Techna Vision for the device "TECHNA VISION AUTO-PERIMETER". The FDA issued a decision of Substantially Equivalent on November 12, 1985. The device falls under product code HPT (Perimeter, Automatic, Ac-Powered), a Class I device regulated under 21 CFR 886.1605. Techna Vision has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1985
Date Received
August 5, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Perimeter, Automatic, Ac-Powered
Device Class
Class I
Regulation Number
886.1605
Review Panel
OP
Submission Type

Other clearances by Techna Vision

  • K862578 — TECHNA VISION CASTING RESIN (July 23, 1986)
  • K853744 — TECHNA VISION, INC.ELECTRIC TABLE (October 17, 1985)
  • K853743 — TECHNA VISION, INC. ELECTRIC CHAIR (October 17, 1985)

Other clearances for product code HPT

  • K092187 — MAIA, MODEL 1 (May 27, 2010)
  • K093213 — GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES (March 12, 2010)
  • K091579 — FORESEE HOME (December 23, 2009)
  • K063310 — TRUEFIELD ANALYZER (August 2, 2007)
  • K050350 — THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP) (April 29, 2005)
  • K023623 — NOVAVISION, MODEL 2.0 (April 22, 2003)
  • K971156 — KASHA VISUAL FIELD SYSTEM (May 28, 1997)
  • K961090 — AUTOMATIC VISUAL FIELD PLOTTER AP-125 (June 17, 1996)
  • K954167 — HUMPHREY FIELD ANALYZER (HFA II) (November 24, 1995)
  • K954037 — FIELD TREND (November 17, 1995)

FDA data resources