Cleared Traditional

TECHNA VISION, INC.ELECTRIC TABLE

K853744 · Techna Vision · Ophthalmic
Oct 1985
Decision
41d
Days
Class 1
Risk

About This 510(k) Submission

K853744 is an FDA 510(k) clearance for the TECHNA VISION, INC.ELECTRIC TABLE, a Table, Instrument, Powered, Ophthalmic (Class I — General Controls, product code HRJ), submitted by Techna Vision (Santee, US). The FDA issued a Cleared decision on October 17, 1985, 41 days after receiving the submission on September 6, 1985. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4855.

Submission Details

510(k) Number K853744 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 1985
Decision Date October 17, 1985
Days to Decision 41 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code HRJ — Table, Instrument, Powered, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4855