FDA 510(k)

Vigilant軟體套件 – Vigilant Master 医療設備

K 號：K210075 · 2022-03-01

決定日期2022-03-01

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

Vigilant Software Suite – Vigilant Master Med is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Kabi AG. It received FDA 510(k) clearance on 2022-03-01 under 510(k) number K210075. 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 Vigilant Software Suite – Vigilant Master Med?

Vigilant Software Suite – Vigilant Master Med is a medical device that received FDA 510(k) clearance on 2022-03-01. The listed applicant is Fresenius Kabi AG. The 510(k) number is K210075.

When did Vigilant Software Suite – Vigilant Master Med receive FDA 510(k) clearance?

Vigilant Software Suite – Vigilant Master Med received FDA 510(k) clearance on 2022-03-01, under 510(k) number K210075.

Who is the listed applicant for Vigilant Software Suite – Vigilant Master Med?

The FDA 510(k) record lists Fresenius Kabi AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vigilant Software Suite – Vigilant Master Med?

The FDA product code for Vigilant Software Suite – Vigilant Master Med is PHC.

其他以 Fresenius Kabi AG 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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