FDA 510(k)

I-Portal 隨身評估系統 - 眨眼儀 (I-PAS)

K 號：K171884 · 2017-11-22

決定日期2017-11-22

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 Portable Assessment System - Nystagmograph (I-PAS) is the device name listed in this FDA 510(k) record. The listed applicant is Neuro Kinetics, Inc.. It received FDA 510(k) clearance on 2017-11-22 under 510(k) number K171884. 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 Portable Assessment System - Nystagmograph (I-PAS)?

I-Portal Portable Assessment System - Nystagmograph (I-PAS) is a medical device that received FDA 510(k) clearance on 2017-11-22. The listed applicant is Neuro Kinetics, Inc.. The 510(k) number is K171884.

When did I-Portal Portable Assessment System - Nystagmograph (I-PAS) receive FDA 510(k) clearance?

I-Portal Portable Assessment System - Nystagmograph (I-PAS) received FDA 510(k) clearance on 2017-11-22, under 510(k) number K171884.

Who is the listed applicant for I-Portal Portable Assessment System - Nystagmograph (I-PAS)?

The FDA 510(k) record lists Neuro Kinetics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-Portal Portable Assessment System - Nystagmograph (I-PAS)?

The FDA product code for I-Portal Portable Assessment System - Nystagmograph (I-PAS) is GWN.

其他以 Neuro Kinetics, Inc. 為申請人之記錄

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相關器械（代碼：GWN）

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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