Cleared Traditional

VISTECH VCTS GLARE TESTER

K853481 · Vistech Consultants, Inc. · Ophthalmic
Oct 1985
Decision
70d
Days
Class 1
Risk

About This 510(k) Submission

K853481 is an FDA 510(k) clearance for the VISTECH VCTS GLARE TESTER, a Chart, Visual Acuity (Class I — General Controls, product code HOX), submitted by Vistech Consultants, Inc. (Dayton, US). The FDA issued a Cleared decision on October 29, 1985, 70 days after receiving the submission on August 20, 1985. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1150.

Submission Details

510(k) Number K853481 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 1985
Decision Date October 29, 1985
Days to Decision 70 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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