FDA 510(k)

Pentaflush

K 號：K214080 · 2022-07-20

決定日期2022-07-20

產品代碼NGT

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

Pentaflush is the device name listed in this FDA 510(k) record. The listed applicant is Pentaferte Italia S.R.L.. It received FDA 510(k) clearance on 2022-07-20 under 510(k) number K214080. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pentaflush?

Pentaflush is a medical device that received FDA 510(k) clearance on 2022-07-20. The listed applicant is Pentaferte Italia S.R.L.. The 510(k) number is K214080.

When did Pentaflush receive FDA 510(k) clearance?

Pentaflush received FDA 510(k) clearance on 2022-07-20, under 510(k) number K214080.

Who is the listed applicant for Pentaflush?

The FDA 510(k) record lists Pentaferte Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pentaflush?

The FDA product code for Pentaflush is NGT.

其他以 Pentaferte Italia S.R.L. 為申請人之記錄

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K211661ENFit腸內針筒（NUTRIFIT）K161141ENFit腸內輸液泵針筒 PENTA ENFit，ENFit腸內輸液泵針筒 NUTRIFIT

相關器械（代碼：NGT）

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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