FDA 510(k)

エクアシールドクローズドシステムトランスファーデバイス

K番号: K221513 · 2023-02-17

決定日2023-02-17

製品コードONB

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

Equashield Closed System Transfer Device is the device name listed in this FDA 510(k) record. The listed applicant is Equashield Medical , Ltd.. It received FDA 510(k) clearance on 2023-02-17 under 510(k) number K221513. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Equashield Closed System Transfer Device?

Equashield Closed System Transfer Device is a medical device that received FDA 510(k) clearance on 2023-02-17. The listed applicant is Equashield Medical , Ltd.. The 510(k) number is K221513.

When did Equashield Closed System Transfer Device receive FDA 510(k) clearance?

Equashield Closed System Transfer Device received FDA 510(k) clearance on 2023-02-17, under 510(k) number K221513.

Who is the listed applicant for Equashield Closed System Transfer Device?

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

What is the FDA product code for Equashield Closed System Transfer Device?

The FDA product code for Equashield Closed System Transfer Device is ONB.

申請者としてEquashield Medical , Ltd.を記載するその他の記録

K170706エクアシールドクローズドシステム薬剤移送装置（CSTD）

公式ソース

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