Cleared Traditional

Insight Infrared Video Goggles

K203082 · Vestibular First · Ear, Nose, Throat

Nov 2020

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K203082 is an FDA 510(k) clearance for the Insight Infrared Video Goggles, a Nystagmograph (Class II — Special Controls, product code GWN), submitted by Vestibular First (Broomall, US). The FDA issued a Cleared decision on November 12, 2020, 30 days after receiving the submission on October 13, 2020. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.1460.

Submission Details

510(k) Number	K203082 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 13, 2020
Decision Date	November 12, 2020
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF