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：K241190 · 2024-05-29

決定日期2024-05-29

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 2024-05-29 under 510(k) number K241190. 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 2024-05-29. The listed applicant is Poonglim Pharmatech, Inc.. The 510(k) number is K241190.

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 2024-05-29, under 510(k) number K241190.

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。

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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。

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官方來源

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