FDA 510(k)

生命盾輸液安全軟體套件

K 號：K252130 · 2026-04-02

決定日期2026-04-02

產品代碼PHC

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

LifeShield Infusion Safety Software Suite is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 2026-04-02 under 510(k) number K252130. The device is classified under product code PHC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LifeShield Infusion Safety Software Suite?

LifeShield Infusion Safety Software Suite is a medical device that received FDA 510(k) clearance on 2026-04-02. The listed applicant is Icu Medical, Inc.. The 510(k) number is K252130.

When did LifeShield Infusion Safety Software Suite receive FDA 510(k) clearance?

LifeShield Infusion Safety Software Suite received FDA 510(k) clearance on 2026-04-02, under 510(k) number K252130.

Who is the listed applicant for LifeShield Infusion Safety Software Suite?

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

What is the FDA product code for LifeShield Infusion Safety Software Suite?

The FDA product code for LifeShield Infusion Safety Software Suite is PHC.

其他以 Icu Medical, 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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相關器械（代碼：PHC）

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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官方來源

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