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FDA 510(k)

單次使用精準過濾針頭組，單次使用精準過濾針頭，單次使用延長針頭組

K 號：K181870 · 2019-02-26

申請人Wuhan W.E.O Science & Technology Development Co., Ltd.
決定日期2019-02-26
產品代碼FPA
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

Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan W.E.O Science & Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2019-02-26 under 510(k) number K181870. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use?

Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use is a medical device that received FDA 510(k) clearance on 2019-02-26. The listed applicant is Wuhan W.E.O Science & Technology Development Co., Ltd.. The 510(k) number is K181870.

When did Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use receive FDA 510(k) clearance?

Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use received FDA 510(k) clearance on 2019-02-26, under 510(k) number K181870.

Who is the listed applicant for Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use?

The FDA 510(k) record lists Wuhan W.E.O Science & Technology Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use?

The FDA product code for Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use is FPA.

相關臨床試驗

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相關器械（代碼：FPA）

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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