FDA 510(k)

EZ-Injec LDV 無菌安全針

K 號：K210444 · 2021-02-16

決定日期2021-02-16

產品代碼QNS

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

EZ-Injec LDV Sterile Safety Needle 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 2021-02-16 under 510(k) number K210444. The device is classified under product code QNS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EZ-Injec LDV Sterile Safety Needle?

EZ-Injec LDV Sterile Safety Needle is a medical device that received FDA 510(k) clearance on 2021-02-16. The listed applicant is Poonglim Pharmatech, Inc.. The 510(k) number is K210444.

When did EZ-Injec LDV Sterile Safety Needle receive FDA 510(k) clearance?

EZ-Injec LDV Sterile Safety Needle received FDA 510(k) clearance on 2021-02-16, under 510(k) number K210444.

Who is the listed applicant for EZ-Injec LDV Sterile Safety Needle?

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 EZ-Injec LDV Sterile Safety Needle?

The FDA product code for EZ-Injec LDV Sterile Safety Needle is QNS.

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 K221860PLPT 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 K192222EZ-Inject單次使用針頭 K172483Kopac 無菌針

相關器械（代碼：QNS）

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。

K242956LDS針；OcuSafe® LDS針；SteriCap® LDS安全針；VitreJect® LDS安全針Ocuject, LLC K231734STERiJECT 低死腔，STERiJECT 無形針Tsk Laboratory International Japan KK

官方來源

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