FDA 510(k)

Volumat 系列

K 號：K220301 · 2023-06-02

決定日期2023-06-02

產品代碼FPA

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

Volumat Line is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Kabi. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K220301. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Volumat Line?

Volumat Line is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is Fresenius Kabi. The 510(k) number is K220301.

When did Volumat Line receive FDA 510(k) clearance?

Volumat Line received FDA 510(k) clearance on 2023-06-02, under 510(k) number K220301.

Who is the listed applicant for Volumat Line?

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

What is the FDA product code for Volumat Line?

The FDA product code for Volumat Line is FPA.

其他以 Fresenius Kabi 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。

K221121Volumat 聚乙烯鹼靜脈注射輸液設備

相關器械（代碼：FPA）

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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