Cleared Traditional

DOT VISUAL ACVITY TEST 2000

K833956 · Good-Lite Co. · Ophthalmic
Jan 1984
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K833956 is an FDA 510(k) clearance for the DOT VISUAL ACVITY TEST 2000, a Chart, Visual Acuity (Class I — General Controls, product code HOX), submitted by Good-Lite Co. (Mchenry, US). The FDA issued a Cleared decision on January 4, 1984, 49 days after receiving the submission on November 16, 1983. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1150.

Submission Details

510(k) Number K833956 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 1983
Decision Date January 04, 1984
Days to Decision 49 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

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

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