myVision Track Model 005— 510(k) K143211

Name: FDA 510(k) clearance K143211
Creator: U.S. Food and Drug Administration
Published: 2015-03-20

Substantially Equivalent

Vital Art and Science Incorporated

FDA 510(k) clearance K143211 for myVision Track Model 005, Substantially Equivalent on 2015-03-20. Applicant: Vital Art and Science Incorporated. Device class: 1.

Clearance details

Applicant: Vital Art and Science Incorporated
Product code: Code HOQ
Device class: Class 1
Regulation: 21 CFR 886.1330
Advisory panel: Ophthalmic
Date received: 2014-11-10
Decision date: 2015-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richardson, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HOQ

view all

K180895 — Alleye2018-06-27
K121738 — MYVISIONTRACK(TM)2013-02-22
K014044 — MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)2002-03-04
K874252 — KREDA DISC1988-01-27
K863429 — MODIFIED DEVICE FOR SELF EXAMINATION OF EYES1987-01-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.