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FDA 510(k)

Trovita健康科學安全-T即食包裝袋，配備ENFit連接器

K 號：K163586 · 2017-03-17

申請人Trovrx, Inc. Dba Trovita Health Science
決定日期2017-03-17
產品代碼PIF
諮詢委員會GU
決定相當於

器材摘要

Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector is the device name listed in this FDA 510(k) record. The listed applicant is Trovrx, Inc. Dba Trovita Health Science. It received FDA 510(k) clearance on 2017-03-17 under 510(k) number K163586. 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 Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector?

Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector is a medical device that received FDA 510(k) clearance on 2017-03-17. The listed applicant is Trovrx, Inc. Dba Trovita Health Science. The 510(k) number is K163586.

When did Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector receive FDA 510(k) clearance?

Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector received FDA 510(k) clearance on 2017-03-17, under 510(k) number K163586.

Who is the listed applicant for Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector?

The FDA 510(k) record lists Trovrx, Inc. Dba Trovita Health Science as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector?

The FDA product code for Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector 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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