FDA 510(k)

PLPT LDV（低死腔）LC（Luer-Cone）无菌針筒，PLPT LDV（低死腔）LL（Luer-Lock）无菌針筒

K 號：K221860 · 2023-09-15

決定日期2023-09-15

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

PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Poonglim Pharmatech, Inc.. It received FDA 510(k) clearance on 2023-09-15 under 510(k) number K221860. 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 PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe?

PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe is a medical device that received FDA 510(k) clearance on 2023-09-15. The listed applicant is Poonglim Pharmatech, Inc.. The 510(k) number is K221860.

When did PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe receive FDA 510(k) clearance?

PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe received FDA 510(k) clearance on 2023-09-15, under 510(k) number K221860.

Who is the listed applicant for PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe?

The FDA 510(k) record lists Poonglim Pharmatech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe?

The FDA product code for PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe is QNQ.

其他以 Poonglim Pharmatech, Inc. 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。

K241190PLPT LDV（低死腔）LC（Luer-Cone）无菌針筒；PLPT LDV（低死腔）LL（Luer-Lock）无菌針筒 K210443PLPT LDV (低死腔) 無菌針筒 K210444EZ-Injec LDV 無菌安全針 K192222EZ-Inject單次使用針頭 K172483Kopac 無菌針

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, Japan K250138小容量0.2毫升針筒Prosum Medical Limited K242291SOL-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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