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FDA 510(k)

無菌單次使用LDV針筒，CHOICARE無菌單次使用LDV針筒

K 號：K213013 · 2022-09-19

申請人Jeil Tech Co., Ltd.
決定日期2022-09-19
產品代碼QNQ
諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於

器材摘要

Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Jeil Tech Co., Ltd.. It received FDA 510(k) clearance on 2022-09-19 under 510(k) number K213013. The device is classified under product code QNQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe?

Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe is a medical device that received FDA 510(k) clearance on 2022-09-19. The listed applicant is Jeil Tech Co., Ltd.. The 510(k) number is K213013.

When did Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe receive FDA 510(k) clearance?

Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe received FDA 510(k) clearance on 2022-09-19, under 510(k) number K213013.

Who is the listed applicant for Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe?

The FDA 510(k) record lists Jeil Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe?

The FDA product code for Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe is QNQ.

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：QNQ）

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。

K252814Profoject™ 低死腔針筒 / Profoject™ 结核菌素針筒；Profoject™ 低死腔針筒（附針）/ Profoject™ 结核菌素針筒（附針）；Profoject™ 低死腔針筒（永久針）/ Profoject™ 结核菌素針筒（永久針）；Profoject™ 低死腔安全針筒 / Profoject™ 结核菌素安全針筒CMT Health PTE., Ltd.K250127TSK 靜脈注射針Tsk Laboratory, JapanK250138小容量0.2毫升針筒Prosum Medical LimitedK242291SOL-M Luer Lock 静脈注射器（低死腔）無針頭，SOL-M 滑尖注射器（低死腔）無針頭，SOL-M Luer Lock 静脈注射器（低死腔）可更換針頭，SOL-CARE Luer Lock 静脈注射器（低死腔）配安全針，SOL-M 滑尖注射器（低死腔）可更換針頭Sol-Millennium Medical, Inc.K232943皮下針-Pro® EDGE™ 低死空間針筒安全裝置Smiths Medical Asd, Inc.K241190PLPT LDV（低死腔）LC（Luer-Cone）无菌針筒；PLPT LDV（低死腔）LL（Luer-Lock）无菌針筒Poonglim Pharmatech, Inc.

官方來源

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