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FDA 510(k)

Nutrisafe 2- ENFit 轉接器

K 號：K151237 · 2016-02-09

申請人Vygon
決定日期2016-02-09
產品代碼PIO
諮詢委員會GU
決定相當於

器材摘要

Nutrisafe 2- ENFit Adaptor is the device name listed in this FDA 510(k) record. The listed applicant is Vygon. It received FDA 510(k) clearance on 2016-02-09 under 510(k) number K151237. The device is classified under product code PIO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nutrisafe 2- ENFit Adaptor?

Nutrisafe 2- ENFit Adaptor is a medical device that received FDA 510(k) clearance on 2016-02-09. The listed applicant is Vygon. The 510(k) number is K151237.

When did Nutrisafe 2- ENFit Adaptor receive FDA 510(k) clearance?

Nutrisafe 2- ENFit Adaptor received FDA 510(k) clearance on 2016-02-09, under 510(k) number K151237.

Who is the listed applicant for Nutrisafe 2- ENFit Adaptor?

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

What is the FDA product code for Nutrisafe 2- ENFit Adaptor?

The FDA product code for Nutrisafe 2- ENFit Adaptor is PIO.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：PIO）

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。

K231299Nutricair腸內ENFit轉接器：ENFit公頭－階梯/耶誕樹型接頭Cair LglK233190ENFit 轉接器Jiangsu Caina Medical Co.,LtdK220165腸內轉換接頭GBUK Group, Ltd.K162254西迪克腸內 ENFit 經過式連接器Cedic S.R.L.

官方來源

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