I-Portal NOTC, VNG and VOG— 510(k) K143607

Name: FDA 510(k) clearance K143607
Creator: U.S. Food and Drug Administration
Published: 2015-07-08

Substantially Equivalent

Neuro Kinetics, Inc.

FDA 510(k) clearance K143607 for I-Portal NOTC, VNG and VOG, Substantially Equivalent on 2015-07-08. 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: 2014-12-19
Decision date: 2015-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K143607

K-number listed on FDA's recall record

Z-2730-2015 — Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.Class II·Terminated·Neuro Kinetics, Inc.·20150721

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143607.

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