Cleared Traditional

EYESEECAM VHIT

K131681 · Interacoustics A/S · Neurology
Sep 2013
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K131681 is an FDA 510(k) clearance for the EYESEECAM VHIT, a Nystagmograph (Class II — Special Controls, product code GWN), submitted by Interacoustics A/S (Assens, DK). The FDA issued a Cleared decision on September 6, 2013, 88 days after receiving the submission on June 10, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1460.

Submission Details

510(k) Number K131681 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2013
Decision Date September 06, 2013
Days to Decision 88 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