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510(k) K884867

OPTIFIELD I AND II AUTOMATED PERIMETERS by Optimed, Inc. — Product Code HPT

K884867 is an FDA 510(k) premarket notification submitted by Optimed, Inc. for the device "OPTIFIELD I AND II AUTOMATED PERIMETERS". The FDA issued a decision of Substantially Equivalent on March 9, 1989. The device falls under product code HPT (Perimeter, Automatic, Ac-Powered), a Class I device regulated under 21 CFR 886.1605. Optimed, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1989
Date Received
November 21, 1988
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 Optimed, Inc.

  • K903462 — OPTIMED GLAUCOMA PRESSURE REGULATOR (October 16, 1990)
  • K890687 — ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER (September 5, 1989)
  • K883458 — OPTIMED ADVANTAGE (November 7, 1988)

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