胎盤血管導管
K 號：K201697 · 2021-05-06
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決定日期2021-05-06
產品代碼FOS
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
Umbilical Vessels Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Haolang Medical USA Corporation. It received FDA 510(k) clearance on 2021-05-06 under 510(k) number K201697. The device is classified under product code FOS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Umbilical Vessels Catheter?
Umbilical Vessels Catheter is a medical device that received FDA 510(k) clearance on 2021-05-06. The listed applicant is Haolang Medical USA Corporation. The 510(k) number is K201697.
When did Umbilical Vessels Catheter receive FDA 510(k) clearance?
Umbilical Vessels Catheter received FDA 510(k) clearance on 2021-05-06, under 510(k) number K201697.
Who is the listed applicant for Umbilical Vessels Catheter?
The FDA 510(k) record lists Haolang Medical USA Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Umbilical Vessels Catheter?
The FDA product code for Umbilical Vessels Catheter is FOS.
相關臨床試驗
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其他以 Haolang Medical USA Corporation 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。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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