FDA 510(k)

AMSure 胃內輸食泵

K 號：K220230 · 2022-11-10

決定日期2022-11-10

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

AMSure Enteral Feeding Pump is the device name listed in this FDA 510(k) record. The listed applicant is Amsino International, Inc.. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K220230. 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 AMSure Enteral Feeding Pump?

AMSure Enteral Feeding Pump is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Amsino International, Inc.. The 510(k) number is K220230.

When did AMSure Enteral Feeding Pump receive FDA 510(k) clearance?

AMSure Enteral Feeding Pump received FDA 510(k) clearance on 2022-11-10, under 510(k) number K220230.

Who is the listed applicant for AMSure Enteral Feeding Pump?

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

What is the FDA product code for AMSure Enteral Feeding Pump?

The FDA product code for AMSure Enteral Feeding Pump is LZH.

其他以 Amsino International, Inc. 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。

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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

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