I-Portal Portable Assessment System - Nystagmograph (I-PAS)— 510(k) K171884

Name: FDA 510(k) clearance K171884
Creator: U.S. Food and Drug Administration
Published: 2017-11-22

Substantially Equivalent

Neuro Kinetics, Inc.

FDA 510(k) clearance K171884 for I-Portal Portable Assessment System - Nystagmograph (I-PAS), Substantially Equivalent on 2017-11-22. Applicant: Neuro Kinetics, Inc.. Device class: 2.

Clearance details

Applicant: Neuro Kinetics, Inc.
Product code: Code GWN
Device class: Class 2
Regulation: 21 CFR 882.1460
Advisory panel: Neurology
Date received: 2017-06-23
Decision date: 2017-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

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