Cleared Traditional

VisualEyes

K163149 · Interacoustics A/S · Neurology
Apr 2017
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K163149 is an FDA 510(k) clearance for the VisualEyes, a Nystagmograph (Class II — Special Controls, product code GWN), submitted by Interacoustics A/S (Middelfart, DK). The FDA issued a Cleared decision on April 26, 2017, 168 days after receiving the submission on November 9, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1460.

Submission Details

510(k) Number K163149 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2016
Decision Date April 26, 2017
Days to Decision 168 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWN — Nystagmograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1460