Cleared Abbreviated

CENTRAL VISION ANALYZER MODEL 1000

K100095 · Vimetrics,Llc. · Ophthalmic
May 2010
Decision
117d
Days
Class 1
Risk

About This 510(k) Submission

K100095 is an FDA 510(k) clearance for the CENTRAL VISION ANALYZER MODEL 1000, a Chart, Visual Acuity (Class I — General Controls, product code HOX), submitted by Vimetrics,Llc. (Media, US). The FDA issued a Cleared decision on May 10, 2010, 117 days after receiving the submission on January 13, 2010. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1150.

Submission Details

510(k) Number K100095 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2010
Decision Date May 10, 2010
Days to Decision 117 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HOX — Chart, Visual Acuity
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1150

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