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510(k) K873911

PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15 by Richmond Products, Inc. — Product Code HIT

K873911 is an FDA 510(k) premarket notification submitted by Richmond Products, Inc. for the device "PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15". The FDA issued a decision of Substantially Equivalent on December 2, 1987. The device falls under product code HIT (Tester, Color Vision), a Class I device regulated under 21 CFR 886.1170. Richmond Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1987
Date Received
September 25, 1987
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 Richmond Products, Inc.

  • K874252 — KREDA DISC (January 27, 1988)
  • K874251 — WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHT (January 11, 1988)
  • K874250 — THREE CHAR. TEST-CHILD & WORTH 4 DOT TEST NEARPT. (January 11, 1988)
  • K873907 — CONFIRMATION TESTS (December 29, 1987)
  • K873908 — H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK. (December 23, 1987)
  • K873916 — 'E' CUBE AND 'E' PAD (December 11, 1987)
  • K873914 — ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT) (December 11, 1987)
  • K873913 — COLOR BOOK ILLUMINATOR STAND (December 2, 1987)
  • K873917 — TONOMETER TAPES (November 2, 1987)
  • K873912 — RICHMOND VISUAL FIELD SCREENER (November 2, 1987)

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)
  • K844694 — TITMUS VISION TESTER II (January 22, 1985)
  • K844365 — COLOR VISION TESTERS (January 2, 1985)
  • K832843 — OSCAR COLOUR VISION TESTER (January 4, 1984)
  • K831074 — OSCAR COLOR VISION TESTER (April 28, 1983)
  • K810700 — CHROMOPS FM-100 COLOR VISION TESTER (April 10, 1981)

FDA data resources