Cleared Traditional

VCTS 6500 SYSTEM

K881023 · Vistech Consultants, Inc. · Ophthalmic
Apr 1988
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K881023 is an FDA 510(k) clearance for the VCTS 6500 SYSTEM, 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 April 1, 1988, 22 days after receiving the submission on March 10, 1988. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1150.

Submission Details

510(k) Number K881023 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1988
Decision Date April 01, 1988
Days to Decision 22 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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