Cleared Traditional

OCCU-TECH VISION TEST

K881971 · Applied Vision Concepts, Inc. · Ophthalmic

Nov 1988

Decision

198d

Days

Class 1

Risk

About This 510(k) Submission

K881971 is an FDA 510(k) clearance for the OCCU-TECH VISION TEST, a Chart, Visual Acuity (Class I — General Controls, product code HOX), submitted by Applied Vision Concepts, Inc. (Portland, US). The FDA issued a Cleared decision on November 25, 1988, 198 days after receiving the submission on May 11, 1988. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1150.

Submission Details

510(k) Number	K881971 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 11, 1988
Decision Date	November 25, 1988
Days to Decision	198 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—