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510(k) K063310

TRUEFIELD ANALYZER by Seeing Machines Limited — Product Code HPT

K063310 is an FDA 510(k) premarket notification submitted by Seeing Machines Limited for the device "TRUEFIELD ANALYZER". The FDA issued a decision of Substantially Equivalent on August 2, 2007. The device falls under product code HPT (Perimeter, Automatic, Ac-Powered), a Class I device regulated under 21 CFR 886.1605.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2007
Date Received
November 2, 2006
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 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)
  • 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)
  • K943234 — MS-30 AUTOMATIC PERIMETER (July 27, 1994)

FDA data resources