FDA 510(k)

ニッシャメディカルテクノロジーズネュートラル電極

K番号: K203494 · 2021-02-23

決定日2021-02-23

製品コードGEI

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Nissha Medical Technologies Neutral Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Nissha Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2021-02-23 under 510(k) number K203494. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Nissha Medical Technologies Neutral Electrodes?

Nissha Medical Technologies Neutral Electrodes is a medical device that received FDA 510(k) clearance on 2021-02-23. The listed applicant is Nissha Medical Technologies, Ltd.. The 510(k) number is K203494.

When did Nissha Medical Technologies Neutral Electrodes receive FDA 510(k) clearance?

Nissha Medical Technologies Neutral Electrodes received FDA 510(k) clearance on 2021-02-23, under 510(k) number K203494.

Who is the listed applicant for Nissha Medical Technologies Neutral Electrodes?

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

What is the FDA product code for Nissha Medical Technologies Neutral Electrodes?

The FDA product code for Nissha Medical Technologies Neutral Electrodes is GEI.

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ニッシャメディカルテクノロジーズネュートラル電極

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：GEI）

公式ソース