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FDA 510(k)

I-Portal神經耳科測試中心，I-Portal影片眼震圖系統，I-Portal可攜式評估系統 - 眼震圖

K 號：K192186 · 2019-11-29

申請人Neurolign USA, LLC
決定日期2019-11-29
產品代碼GWN
諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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