FDA 510(k)

皮下針-Pro® EDGE™ 低死空間針筒安全裝置

K 號：K232943 · 2024-05-31

決定日期2024-05-31

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

Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2024-05-31 under 510(k) number K232943. 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 Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe?

Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe is a medical device that received FDA 510(k) clearance on 2024-05-31. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K232943.

When did Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe receive FDA 510(k) clearance?

Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe received FDA 510(k) clearance on 2024-05-31, under 510(k) number K232943.

Who is the listed applicant for Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe?

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

What is the FDA product code for Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe?

The FDA product code for Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe is QNQ.

其他以 Smiths Medical Asd, 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。

K210833Portex BLUxl 長型氣管切開管，BLUxl 吸痰輔助長型氣管切開管，BLUxl 長型氣管切開管內管 K211634皮下針-Pro EDGE 安全設備 K192375Intellifuse 藥物給藥及 Intellifuse 靜脈輸注套裝 K181699第一級對流加熱器 K172800Portex® 鋸刺點脊椎針配NRFit™ 插頭，Portex® 圆錐點脊椎針配NRFit™ 插頭 K172823Portex NRFit 硬脊膜針

查看所有 16 項裝置 →

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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