Cleared Traditional

VisualEyes

K152112 · Interacoustics A/S · Neurology
Dec 2015
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K152112 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 December 29, 2015, 153 days after receiving the submission on July 29, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1460.

Submission Details

510(k) Number K152112 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2015
Decision Date December 29, 2015
Days to Decision 153 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