FDA 510(k)

DIXI醫療微深微-宏深電極

K 號：K202087 · 2021-11-18

決定日期2021-11-18

產品代碼GZL

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 Microdeep Micro-Macro Depth Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Dixi Medical. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K202087. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DIXI Medical Microdeep Micro-Macro Depth Electrodes?

DIXI Medical Microdeep Micro-Macro Depth Electrodes is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is Dixi Medical. The 510(k) number is K202087.

When did DIXI Medical Microdeep Micro-Macro Depth Electrodes receive FDA 510(k) clearance?

DIXI Medical Microdeep Micro-Macro Depth Electrodes received FDA 510(k) clearance on 2021-11-18, under 510(k) number K202087.

Who is the listed applicant for DIXI Medical Microdeep Micro-Macro Depth Electrodes?

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 Microdeep Micro-Macro Depth Electrodes?

The FDA product code for DIXI Medical Microdeep Micro-Macro Depth Electrodes is GZL.

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。

K201931迪西醫療手術中硬膜下電極（條狀和網格）K170959DIXI醫療微深層電極

相關器械（代碼：GZL）

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。

官方來源

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