Cleared Traditional

I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph

K192186 · Neurolign USA, LLC · Ear, Nose, Throat

Nov 2019

Decision

109d

Days

Class 2

Risk

About This 510(k) Submission

K192186 is an FDA 510(k) clearance for the I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph, a Nystagmograph (Class II — Special Controls, product code GWN), submitted by Neurolign USA, LLC (Pittsburgh, US). The FDA issued a Cleared decision on November 29, 2019, 109 days after receiving the submission on August 12, 2019. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.1460.

Submission Details

510(k) Number	K192186 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 2019
Decision Date	November 29, 2019
Days to Decision	109 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF