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FDA 510(k)

迪西醫療手術中硬膜下電極（條狀和網格）

K 號：K201931 · 2021-10-02

申請人Dixi Medical
決定日期2021-10-02
產品代碼GYC
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

Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) is the device name listed in this FDA 510(k) record. The listed applicant is Dixi Medical. It received FDA 510(k) clearance on 2021-10-02 under 510(k) number K201931. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)?

Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) is a medical device that received FDA 510(k) clearance on 2021-10-02. The listed applicant is Dixi Medical. The 510(k) number is K201931.

When did Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) receive FDA 510(k) clearance?

Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) received FDA 510(k) clearance on 2021-10-02, under 510(k) number K201931.

Who is the listed applicant for Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)?

The FDA 510(k) record lists Dixi Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)?

The FDA product code for Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) is GYC.

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 Dixi Medical 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。

K202087DIXI醫療微深微-宏深電極K170959DIXI醫療微深層電極

相關器械（代碼：GYC）

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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官方來源

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