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510(k) K821940

THE HUMPHREY FIELD ANALYZER MODEL 610 by Zeiss Humphrey System — Product Code HPT

K821940 is an FDA 510(k) premarket notification submitted by Zeiss Humphrey System for the device "THE HUMPHREY FIELD ANALYZER MODEL 610". The FDA issued a decision of Substantially Equivalent on July 28, 1982. The device falls under product code HPT (Perimeter, Automatic, Ac-Powered), a Class I device regulated under 21 CFR 886.1605. Zeiss Humphrey System has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1982
Date Received
June 29, 1982
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 Zeiss Humphrey System

  • K942439 — ZEISS OPMILAS 144 SURGICAL LASERS (July 1, 1994)
  • K923211 — DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE (November 8, 1993)
  • K923348 — OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED (December 10, 1992)
  • K852639 — HUMPHREY FIELD ANALYZER MODEL 630 (September 18, 1985)
  • K852638 — HUMPHREY IMAGE ANALYZER MODEL 110 (August 12, 1985)
  • K802029 — OBJECTIVE REFRACTOR (November 12, 1980)
  • K781994 — AUTOKERATOMETER, INSTRUMENT (February 12, 1979)
  • K782096 — INSTRUMENTS, OVERREFRACTION SYSTEM (January 26, 1979)

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