Cleared Traditional

TECHNA VISION AUTO-PERIMETER

K853290 · Techna Vision · Ophthalmic
Nov 1985
Decision
99d
Days
Class 1
Risk

About This 510(k) Submission

K853290 is an FDA 510(k) clearance for the TECHNA VISION AUTO-PERIMETER, a Perimeter, Automatic, Ac-powered (Class I — General Controls, product code HPT), submitted by Techna Vision (Santee, US). The FDA issued a Cleared decision on November 12, 1985, 99 days after receiving the submission on August 5, 1985. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1605.

Submission Details

510(k) Number K853290 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 1985
Decision Date November 12, 1985
Days to Decision 99 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HPT — Perimeter, Automatic, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1605

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