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510(k) K854047

IN-HOME VISION MONITORING KIT by Rich-Larky Company, Inc. — Product Code HOX

K854047 is an FDA 510(k) premarket notification submitted by Rich-Larky Company, Inc. for the device "IN-HOME VISION MONITORING KIT". The FDA issued a decision of Substantially Equivalent on December 13, 1985. The device falls under product code HOX (Chart, Visual Acuity), a Class I device regulated under 21 CFR 886.1150.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1985
Date Received
October 3, 1985
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 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