Home / 510(k) Clearances / K954167

510(k) K954167

HUMPHREY FIELD ANALYZER (HFA II) by Carl Zeiss, Inc. — Product Code HPT

K954167 is an FDA 510(k) premarket notification submitted by Carl Zeiss, Inc. for the device "HUMPHREY FIELD ANALYZER (HFA II)". The FDA issued a decision of Substantially Equivalent on November 24, 1995. The device falls under product code HPT (Perimeter, Automatic, Ac-Powered), a Class I device regulated under 21 CFR 886.1605. Carl Zeiss, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1995
Date Received
September 5, 1995
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 Carl Zeiss, Inc.

  • K013402 — VISULAS 532S (November 14, 2001)
  • K003885 — VISULAS YAG II (February 22, 2001)
  • K993357 — IOLMASTER (March 20, 2000)
  • K983868 — OPMI TWINER SURGICAL MICROSCOPE (January 29, 1999)
  • K965139 — SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM (April 23, 1997)
  • K961380 — CPC PROBE (March 17, 1997)
  • K961171 — HUMPHREY OCT SCANNER (June 21, 1996)
  • K952894 — VISULINK 900 ARGON (August 14, 1995)
  • K950985 — ZEISS ENDOLIVE STERO ENDOSCOPE (March 29, 1995)
  • K931478 — ZEISS OPMI L STEREO-LAPAROSCOPE (September 28, 1994)

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)
  • K954037 — FIELD TREND (November 17, 1995)
  • K943234 — MS-30 AUTOMATIC PERIMETER (July 27, 1994)

FDA data resources