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510(k) K873909

READING CHARTS-CARDS (DISTANCE AND NEARPOINT) by Richmond Products, Inc. — Product Code HOX

K873909 is an FDA 510(k) premarket notification submitted by Richmond Products, Inc. for the device "READING CHARTS-CARDS (DISTANCE AND NEARPOINT)". The FDA issued a decision of Substantially Equivalent on October 28, 1987. The device falls under product code HOX (Chart, Visual Acuity), a Class I device regulated under 21 CFR 886.1150. Richmond Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1987
Date Received
September 25, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chart, Visual Acuity
Device Class
Class I
Regulation Number
886.1150
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)
  • K873911 — PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15 (December 2, 1987)
  • K873912 — RICHMOND VISUAL FIELD SCREENER (November 2, 1987)

Other clearances for product code HOX

  • K100095 — CENTRAL VISION ANALYZER MODEL 1000 (May 10, 2010)
  • K944156 — HEINE LAMBDA 100 (January 12, 1995)
  • K881971 — OCCU-TECH VISION TEST (November 25, 1988)
  • K883337 — PL 20/20 INFANT VISION TESTER (October 31, 1988)
  • K882634 — VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE (July 15, 1988)
  • K881358 — PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM (June 27, 1988)
  • K881059 — MCT 8000 (MULTI-VISION CONTRAST TESTER) (April 4, 1988)
  • K881023 — VCTS 6500 SYSTEM (April 1, 1988)
  • K881022 — VCTS MARKETING PROGRAM SYSTEM (April 1, 1988)
  • K881021 — VCTS 700S SYSTEM (April 1, 1988)

FDA data resources