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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影片眼動圖眼追蹤系統

K 號：K181025 · 2018-07-24

申請人Neuro Kinetics, Inc.
決定日期2018-07-24
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 Video Oculography Eye Tracking System 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 2018-07-24 under 510(k) number K181025. 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 Video Oculography Eye Tracking System?

I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System is a medical device that received FDA 510(k) clearance on 2018-07-24. The listed applicant is Neuro Kinetics, Inc.. The 510(k) number is K181025.

When did I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System receive FDA 510(k) clearance?

I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System received FDA 510(k) clearance on 2018-07-24, under 510(k) number K181025.

Who is the listed applicant for I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System?

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 Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System?

The FDA product code for I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System 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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Neuro Kinetics, Inc. 為申請人之記錄

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。

K171884I-Portal 隨身評估系統 - 眨眼儀 (I-PAS)

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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