FDA 510(k)

Plum 360™ 灌注系統搭配MedNet/智能卡即插即用模組

K 號：K161469 · 2017-03-28

決定日期2017-03-28

產品代碼FRN

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

Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module is the device name listed in this FDA 510(k) record. The listed applicant is Hospira, Inc.. It received FDA 510(k) clearance on 2017-03-28 under 510(k) number K161469. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module?

Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module is a medical device that received FDA 510(k) clearance on 2017-03-28. The listed applicant is Hospira, Inc.. The 510(k) number is K161469.

When did Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module receive FDA 510(k) clearance?

Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module received FDA 510(k) clearance on 2017-03-28, under 510(k) number K161469.

Who is the listed applicant for Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module?

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

What is the FDA product code for Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module?

The FDA product code for Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module is FRN.

其他以 Hospira, Inc. 為申請人之記錄

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相關器械（代碼：FRN）

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