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FDA 510(k)

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

K-Number: K192186 · 2019-11-29

ApplicantNeurolign USA, LLC
Decision Date2019-11-29
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph is the device name listed in this FDA 510(k) record. The listed applicant is Neurolign USA, LLC. It received FDA 510(k) clearance on 2019-11-29 under 510(k) number K192186. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph?

I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph is a medical device that received FDA 510(k) clearance on 2019-11-29. The listed applicant is Neurolign USA, LLC. The 510(k) number is K192186.

When did I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph receive FDA 510(k) clearance?

I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph received FDA 510(k) clearance on 2019-11-29, under 510(k) number K192186.

Who is the listed applicant for I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph?

The FDA 510(k) record lists Neurolign USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph?

The FDA product code for I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph is GWN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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