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510(k) K100095

CENTRAL VISION ANALYZER MODEL 1000 by Vimetrics,Llc. — Product Code HOX

K100095 is an FDA 510(k) premarket notification submitted by Vimetrics,Llc. for the device "CENTRAL VISION ANALYZER MODEL 1000". The FDA issued a decision of Substantially Equivalent on May 10, 2010. 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
May 10, 2010
Date Received
January 13, 2010
Clearance Type
Abbreviated
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

  • 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)
  • K880647 — ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) (April 1, 1988)
  • K881023 — VCTS 6500 SYSTEM (April 1, 1988)
  • K881021 — VCTS 700S SYSTEM (April 1, 1988)
  • K881022 — VCTS MARKETING PROGRAM SYSTEM (April 1, 1988)

FDA data resources