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510(k) K831074

OSCAR COLOR VISION TESTER by Carl Zeiss, Inc. — Product Code HIT

K831074 is an FDA 510(k) premarket notification submitted by Carl Zeiss, Inc. for the device "OSCAR COLOR VISION TESTER". The FDA issued a decision of Substantially Equivalent on April 28, 1983. The device falls under product code HIT (Tester, Color Vision), a Class I device regulated under 21 CFR 886.1170. Carl Zeiss, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1983
Date Received
April 4, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Color Vision
Device Class
Class I
Regulation Number
886.1170
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)
  • K954167 — HUMPHREY FIELD ANALYZER (HFA II) (November 24, 1995)
  • K952894 — VISULINK 900 ARGON (August 14, 1995)
  • K950985 — ZEISS ENDOLIVE STERO ENDOSCOPE (March 29, 1995)

Other clearances for product code HIT

  • K903001 — SLIMCATH (TM) (June 25, 1991)
  • K875026 — ANOMALOSCOPE PLATE TEST - 5 [APT-5] (February 5, 1988)
  • K873908 — H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK. (December 23, 1987)
  • K873911 — PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15 (December 2, 1987)
  • K844694 — TITMUS VISION TESTER II (January 22, 1985)
  • K844365 — COLOR VISION TESTERS (January 2, 1985)
  • K832843 — OSCAR COLOUR VISION TESTER (January 4, 1984)
  • K810700 — CHROMOPS FM-100 COLOR VISION TESTER (April 10, 1981)

FDA data resources