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FDA 510(k)

一次性電極式電腦電流圖（型號：DL、E-CAP、FLEX-CAP）

K 號：K200162 · 2020-04-21

申請人Wuhan Greentek Pty , Ltd.
決定日期2020-04-21
產品代碼GXY
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

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Greentek Pty , Ltd.. It received FDA 510(k) clearance on 2020-04-21 under 510(k) number K200162. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)?

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is a medical device that received FDA 510(k) clearance on 2020-04-21. The listed applicant is Wuhan Greentek Pty , Ltd.. The 510(k) number is K200162.

When did Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) receive FDA 510(k) clearance?

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) received FDA 510(k) clearance on 2020-04-21, under 510(k) number K200162.

Who is the listed applicant for Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)?

The FDA 510(k) record lists Wuhan Greentek Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)?

The FDA product code for Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is GXY.

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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其他以 Wuhan Greentek Pty , Ltd. 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。

K212787GT5 適電與磨損膠

相關器械（代碼：GXY）

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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