Cleared Traditional

MCT 8000 (MULTI-VISION CONTRAST TESTER)

K881059 · Vistech Consultants, Inc. · Ophthalmic
Apr 1988
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K881059 is an FDA 510(k) clearance for the MCT 8000 (MULTI-VISION CONTRAST 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 April 4, 1988, 24 days after receiving the submission on March 11, 1988. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1150.

Submission Details

510(k) Number K881059 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 1988
Decision Date April 04, 1988
Days to Decision 24 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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