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FDA 510(k)

BD Univia RightFit 經營管擴張套件及過渡式适配器

K 號：K200082 · 2020-07-30

申請人Mps Medical, Inc.
決定日期2020-07-30
產品代碼PIF
諮詢委員會GU
決定相當於

器材摘要

BD Univia RightFit Enteral Extension Sets and Transitional Adapters is the device name listed in this FDA 510(k) record. The listed applicant is Mps Medical, Inc.. It received FDA 510(k) clearance on 2020-07-30 under 510(k) number K200082. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BD Univia RightFit Enteral Extension Sets and Transitional Adapters?

BD Univia RightFit Enteral Extension Sets and Transitional Adapters is a medical device that received FDA 510(k) clearance on 2020-07-30. The listed applicant is Mps Medical, Inc.. The 510(k) number is K200082.

When did BD Univia RightFit Enteral Extension Sets and Transitional Adapters receive FDA 510(k) clearance?

BD Univia RightFit Enteral Extension Sets and Transitional Adapters received FDA 510(k) clearance on 2020-07-30, under 510(k) number K200082.

Who is the listed applicant for BD Univia RightFit Enteral Extension Sets and Transitional Adapters?

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

What is the FDA product code for BD Univia RightFit Enteral Extension Sets and Transitional Adapters?

The FDA product code for BD Univia RightFit Enteral Extension Sets and Transitional Adapters is PIF.

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：PIF）

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。

K260110danumed 食道造口按鈕擴充組Danumed Medizintechnik GmbHK253715Edi 尿管 ENFit 6Fr/48 cm (6893166)；Edi 尿管 ENFit 6Fr/49cm (6893273)；Edi 尿管 ENFit 6Fr/50cm (6893274)；Edi 尿管 ENFit 8Fr/50cm (6893275)；Edi 尿管 ENFit 8Fr/100cm (6893276)；Edi 尿管 ENFit 8Fr/125cm (6893277)；Edi 尿管 ENFit 12Fr/125cm (6893278)；Edi 尿管 ENFit 16Fr/125cm (6893279)Maquet Critical Care ABK254170經皮內視鏡胃造口術（PEG）套件Degania Silicone , Ltd.K242917腸內引流系統，腸內藥劑吸管HMC Premedical S.p.A.K250481延伸喂食設備搭配ENFit™連接器SKY Medical, a.s.K240052一次性腸內營養輸注套組Beijing L&Z Medical Technology Development Co., Ltd.

官方來源

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