FDA 510(k)

Volumat 聚乙烯鹼靜脈注射輸液設備

K 號：K221121 · 2023-06-16

決定日期2023-06-16

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 Polyethylene I.V. Administration Set is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Kabi. It received FDA 510(k) clearance on 2023-06-16 under 510(k) number K221121. 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 Polyethylene I.V. Administration Set?

Volumat Polyethylene I.V. Administration Set is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Fresenius Kabi. The 510(k) number is K221121.

When did Volumat Polyethylene I.V. Administration Set receive FDA 510(k) clearance?

Volumat Polyethylene I.V. Administration Set received FDA 510(k) clearance on 2023-06-16, under 510(k) number K221121.

Who is the listed applicant for Volumat Polyethylene I.V. Administration Set?

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 Polyethylene I.V. Administration Set?

The FDA product code for Volumat Polyethylene I.V. Administration Set is FPA.

其他以 Fresenius Kabi 為申請人之記錄

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K220301Volumat 系列

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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