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FDA 510(k)

內腸針筒配ENFit連接器（10 ml至60 ml），內腸針筒配ENFit低劑量針頭（1 ml至5 ml）

K 號：K162188 · 2016-09-22

申請人Vr Medical Technology
決定日期2016-09-22
產品代碼PNR
諮詢委員會GU
決定相當於

器材摘要

Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) is the device name listed in this FDA 510(k) record. The listed applicant is Vr Medical Technology. It received FDA 510(k) clearance on 2016-09-22 under 510(k) number K162188. 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 Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)?

Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) is a medical device that received FDA 510(k) clearance on 2016-09-22. The listed applicant is Vr Medical Technology. The 510(k) number is K162188.

When did Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) receive FDA 510(k) clearance?

Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) received FDA 510(k) clearance on 2016-09-22, under 510(k) number K162188.

Who is the listed applicant for Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)?

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

What is the FDA product code for Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)?

The FDA product code for Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) is PNR.

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：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。

K252483腸內針筒（20ml, 60ml）Chirana T.Injecta,A.S.K253268Profoject 鼻胃/口內喂養注射器；Profoject 可重用鼻胃/口內喂養注射器（型號A，型號B）；Profoject ENFit 轉接器；Profoject 鼻胃喂養注射器蓋CMT Health PTE., Ltd.K251585Profoject™ 給藥注射器CMT Health PTE., Ltd.K243652Monoject™ 飲食針筒配ENFit連接器（401SE）；Monoject™ 飲食針筒配ENFit連接器（403SE）；Monoject™ 飲食針筒配ENFit連接器（406SE）；Monoject™ 飲食針筒配ENFit連接器（412SE）；Monoject™ 飲食針筒配ENFit連接器（435SE）；Monoject™ 飲食針筒配ENFit連接器（460SE）CardinalhealthK231300Nutricair 內腸注射器配ENFitCair LglK222772口服/腸內針筒配ENFit連接器Anhui Tiankang Medical Technology Co., Ltd.

官方來源

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