FDA 510(k)

Equashield 關閉系統輸送裝置

K 號：K221513 · 2023-02-17

決定日期2023-02-17

產品代碼ONB

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Equashield Medical , Ltd. 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。

K170706Equashield 關閉系統藥物轉移裝置 (CSTD)

相關器械（代碼：ONB）

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。

K251722ProSeal™ 轉移注射器（421120、421130、421140）Epic Medical Pte. , Ltd.K253033Chemfort® 28天 20mm 藥瓶適配器及 13mm 轉換器Simplivia Healthcare , Ltd.K250059BD PhaSeal™ Optima 連接組 (C83-O)；BD PhaSeal™ Optima 尖嘴組 (C180-O)Becton, Dickinson and Company K251411Chemfort 女性路氏釘釋針適配器Simplivia Healthcare , Ltd.K251340ProSeal™ 內袋釘針配附加孔 (423370ST, 423370)Epic Medical Pte. , Ltd.K243976ZeroClear™ 袋裝取用器（423100）Epic Medical Pte. , Ltd.

官方來源

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