I-Portal Neuro Otologic Test Center +2 more— 510(k) K181025

Name: FDA 510(k) clearance K181025
Creator: U.S. Food and Drug Administration
Published: 2018-07-24

Substantially Equivalent

Neuro Kinetics, Inc.

FDA 510(k) clearance K181025 for I-Portal Neuro Otologic Test Center +2 more, Substantially Equivalent on 2018-07-24. Applicant: Neuro Kinetics, Inc.. Device class: 2.

Clearance details

Device name as filed: I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System
Applicant: Neuro Kinetics, Inc.
Product code: Code GWN
Device class: Class 2
Regulation: 21 CFR 882.1460
Advisory panel: Neurology
Date received: 2018-04-18
Decision date: 2018-07-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.