I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph— 510(k) K192186

Name: FDA 510(k) clearance K192186
Creator: U.S. Food and Drug Administration
Published: 2019-11-29

Substantially Equivalent

Neurolign USA, LLC

FDA 510(k) clearance K192186 for I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph, Substantially Equivalent on 2019-11-29. Applicant: Neurolign USA, LLC. Device class: 2.

Clearance details

Applicant: Neurolign USA, LLC
Product code: Code GWN
Device class: Class 2
Regulation: 21 CFR 882.1460
Advisory panel: Neurology
Date received: 2019-08-12
Decision date: 2019-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

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