Cleared Traditional

VisualEyes

K200534 · Interacoustics A/S · Ear, Nose, Throat
Aug 2020
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K200534 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 August 12, 2020, 163 days after receiving the submission on March 2, 2020. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.1460.

Submission Details

510(k) Number K200534 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2020
Decision Date August 12, 2020
Days to Decision 163 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

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

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