FDA 510(k)

一次性輸液袋，用於輸注營養

K 號：K222622 · 2023-02-16

申請人Beijing L&Z Medical Technology Development Co., Ltd.

決定日期2023-02-16

產品代碼KPE

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

Disposable Infusion Bag for Parenteral Nutrition is the device name listed in this FDA 510(k) record. The listed applicant is Beijing L&Z Medical Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2023-02-16 under 510(k) number K222622. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Infusion Bag for Parenteral Nutrition?

Disposable Infusion Bag for Parenteral Nutrition is a medical device that received FDA 510(k) clearance on 2023-02-16. The listed applicant is Beijing L&Z Medical Technology Development Co., Ltd.. The 510(k) number is K222622.

When did Disposable Infusion Bag for Parenteral Nutrition receive FDA 510(k) clearance?

Disposable Infusion Bag for Parenteral Nutrition received FDA 510(k) clearance on 2023-02-16, under 510(k) number K222622.

Who is the listed applicant for Disposable Infusion Bag for Parenteral Nutrition?

The FDA 510(k) record lists Beijing L&Z Medical Technology Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Infusion Bag for Parenteral Nutrition?

The FDA product code for Disposable Infusion Bag for Parenteral Nutrition is KPE.

其他以 Beijing L&Z Medical Technology Development Co., Ltd. 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。

K252079一次性輸液袋，用於輸注營養 K240052一次性腸內營養輸注套組

相關器械（代碼：KPE）

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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