FDA 510(k)

CADD黃色高容量輸注套件，配備NRFit連接器

K 號：K172592 · 2018-05-17

決定日期2018-05-17

產品代碼PWH

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

CADD Yellow High Volume Administration Set with NRFit connector is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2018-05-17 under 510(k) number K172592. The device is classified under product code PWH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CADD Yellow High Volume Administration Set with NRFit connector?

CADD Yellow High Volume Administration Set with NRFit connector is a medical device that received FDA 510(k) clearance on 2018-05-17. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K172592.

When did CADD Yellow High Volume Administration Set with NRFit connector receive FDA 510(k) clearance?

CADD Yellow High Volume Administration Set with NRFit connector received FDA 510(k) clearance on 2018-05-17, under 510(k) number K172592.

Who is the listed applicant for CADD Yellow High Volume Administration Set with NRFit connector?

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

What is the FDA product code for CADD Yellow High Volume Administration Set with NRFit connector?

The FDA product code for CADD Yellow High Volume Administration Set with NRFit connector is PWH.

其他以 Smiths Medical Asd, Inc. 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。

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查看所有 16 項裝置 →

相關器械（代碼：PWH）

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。

K221319BD Alaris™ 泵硬脊膜外輸液套組Care Fusion K211649PCEA 靜脈注射針筒組Baxter Healthcare Corporation K162219CADD® 注射用一次性產品系列，配備NRFit™ 接頭Smiths Medical Asd, Inc.

官方來源

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