FDA 510(k)

PUGGLE 飲食輸送泵及輸送組

K 號：K200051 · 2020-09-25

決定日期2020-09-25

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

PUGGLE Enteral Feeding Pump and Feeding Set 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 2020-09-25 under 510(k) number K200051. 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 PUGGLE Enteral Feeding Pump and Feeding Set?

PUGGLE Enteral Feeding Pump and Feeding Set is a medical device that received FDA 510(k) clearance on 2020-09-25. The listed applicant is Amsino International, Inc.. The 510(k) number is K200051.

When did PUGGLE Enteral Feeding Pump and Feeding Set receive FDA 510(k) clearance?

PUGGLE Enteral Feeding Pump and Feeding Set received FDA 510(k) clearance on 2020-09-25, under 510(k) number K200051.

Who is the listed applicant for PUGGLE Enteral Feeding Pump and Feeding Set?

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 PUGGLE Enteral Feeding Pump and Feeding Set?

The FDA product code for PUGGLE Enteral Feeding Pump and Feeding Set 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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