FDA 510(k)

Luminoah FLOW™腸內營養系統

K 號：K253558 · 2026-04-20

決定日期2026-04-20

產品代碼LZH

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

Luminoah FLOW™ Enteral Nutrition System is the device name listed in this FDA 510(k) record. The listed applicant is Luminoah. It received FDA 510(k) clearance on 2026-04-20 under 510(k) number K253558. The device is classified under product code LZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Luminoah FLOW™ Enteral Nutrition System?

Luminoah FLOW™ Enteral Nutrition System is a medical device that received FDA 510(k) clearance on 2026-04-20. The listed applicant is Luminoah. The 510(k) number is K253558.

When did Luminoah FLOW™ Enteral Nutrition System receive FDA 510(k) clearance?

Luminoah FLOW™ Enteral Nutrition System received FDA 510(k) clearance on 2026-04-20, under 510(k) number K253558.

Who is the listed applicant for Luminoah FLOW™ Enteral Nutrition System?

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

What is the FDA product code for Luminoah FLOW™ Enteral Nutrition System?

The FDA product code for Luminoah FLOW™ Enteral Nutrition System is LZH.

相關器械（代碼：LZH）

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。

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：LZH）

官方來源