Cleared Traditional

VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE

K882634 · Vistech Consultants, Inc. · Ophthalmic
Jul 1988
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K882634 is an FDA 510(k) clearance for the VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE, 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 July 15, 1988, 18 days after receiving the submission on June 27, 1988. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1150.

Submission Details

510(k) Number K882634 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 1988
Decision Date July 15, 1988
Days to Decision 18 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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