Cleared Traditional

TITMUS VISION TESTER II

K844694 · Titmus Optical, Inc. · Ophthalmic
Jan 1985
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K844694 is an FDA 510(k) clearance for the TITMUS VISION TESTER II, a Tester, Color Vision (Class I — General Controls, product code HIT), submitted by Titmus Optical, Inc. (Petersburg, US). The FDA issued a Cleared decision on January 22, 1985, 50 days after receiving the submission on December 3, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1170.

Submission Details

510(k) Number K844694 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 1984
Decision Date January 22, 1985
Days to Decision 50 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code HIT — Tester, Color Vision
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1170

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