FDA 510(k)

ディキ・メディカルインтраオペレーションサブドゥラル電極（ストリップおよびグリッド）

K番号: K201931 · 2021-10-02

決定日2021-10-02

製品コードGYC

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてDixi Medicalを記載するその他の記録

K202087ディキ・メディカルマイクロディープマイクロ・マクロディープ電極 K170959ディキ・メディカルマイクロディープディープエレクトロード

公式ソース

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