Profoject™ Enteral Feeding Syringe
K 號：K251585 · 2025-07-18
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器材摘要
Profoject™ Enteral Feeding Syringe is the device name listed in this FDA 510(k) record. The listed applicant is CMT Health PTE., Ltd.. It received FDA 510(k) clearance on 2025-07-18 under 510(k) number K251585. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Profoject™ Enteral Feeding Syringe?
Profoject™ Enteral Feeding Syringe is a medical device that received FDA 510(k) clearance on 2025-07-18. The listed applicant is CMT Health PTE., Ltd.. The 510(k) number is K251585.
When did Profoject™ Enteral Feeding Syringe receive FDA 510(k) clearance?
Profoject™ Enteral Feeding Syringe received FDA 510(k) clearance on 2025-07-18, under 510(k) number K251585.
Who is the listed applicant for Profoject™ Enteral Feeding Syringe?
The FDA 510(k) record lists CMT Health PTE., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Profoject™ Enteral Feeding Syringe?
The FDA product code for Profoject™ Enteral Feeding Syringe is PNR.
相關臨床試驗
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其他以 CMT Health PTE., Ltd. 為申請人之記錄
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。
K262215Profoject™ Safety Sliding Blood Collection SetK261372Profoject™ LOR SyringeK261829Profoject™ Dual-Safety Pen NeedlesK260739Profoject™ Pen Needles (Model A; Model B)K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleK260855Profoject™ Safety Pen Needles
相關器械（代碼：PNR）
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。
K252483Enteral Syringe (20ml, 60ml)Chirana T.Injecta,A.S.K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes CapCMT Health PTE., Ltd.K243652Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE)CardinalhealthK231300Nutricair Enteral Syringe with ENFitCair LglK222772Oral/Enteral Syringe with ENFit connectorAnhui Tiankang Medical Technology Co., Ltd.K211661ENFit enteral syringes (NUTRIFIT)Pentaferte Italia S.R.L.
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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