延伸喂食設備搭配ENFit™連接器
K 號：K250481 · 2025-04-18
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器材摘要
Extension Feeding Set with ENFit™ Connectors is the device name listed in this FDA 510(k) record. The listed applicant is SKY Medical, a.s.. It received FDA 510(k) clearance on 2025-04-18 under 510(k) number K250481. 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 Extension Feeding Set with ENFit™ Connectors?
Extension Feeding Set with ENFit™ Connectors is a medical device that received FDA 510(k) clearance on 2025-04-18. The listed applicant is SKY Medical, a.s.. The 510(k) number is K250481.
When did Extension Feeding Set with ENFit™ Connectors receive FDA 510(k) clearance?
Extension Feeding Set with ENFit™ Connectors received FDA 510(k) clearance on 2025-04-18, under 510(k) number K250481.
Who is the listed applicant for Extension Feeding Set with ENFit™ Connectors?
The FDA 510(k) record lists SKY Medical, a.s. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Extension Feeding Set with ENFit™ Connectors?
The FDA product code for Extension Feeding Set with ENFit™ Connectors 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。
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.K240052一次性腸內營養輸注套組Beijing L&Z Medical Technology Development Co., Ltd.K233034Mobility+ 飲食輔助系統 非處方藥Rockfield Medical
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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