FDA 510(k)

パーシャル栄養用投与袋

K番号: K252079 · 2026-04-02

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

決定日2026-04-02

製品コードKPE

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

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 2026-04-02 under 510(k) number K252079. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

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 2026-04-02. The listed applicant is Beijing L&Z Medical Technology Development Co., Ltd.. The 510(k) number is K252079.

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 2026-04-02, under 510(k) number K252079.

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.

申請者としてBeijing L&Z Medical Technology Development Co., Ltd.を記載するその他の記録

K240052disposable エンタルフィードイングセット K222622パーシャル栄養用投与袋

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