Avoset 靜脈輸液泵系統
K 號：K213744 · 2023-03-10
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決定日期2023-03-10
產品代碼FRN
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
Avoset Infusion Pump System is the device name listed in this FDA 510(k) record. The listed applicant is Eitan Medical , Ltd.. It received FDA 510(k) clearance on 2023-03-10 under 510(k) number K213744. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Avoset Infusion Pump System?
Avoset Infusion Pump System is a medical device that received FDA 510(k) clearance on 2023-03-10. The listed applicant is Eitan Medical , Ltd.. The 510(k) number is K213744.
When did Avoset Infusion Pump System receive FDA 510(k) clearance?
Avoset Infusion Pump System received FDA 510(k) clearance on 2023-03-10, under 510(k) number K213744.
Who is the listed applicant for Avoset Infusion Pump System?
The FDA 510(k) record lists Eitan Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Avoset Infusion Pump System?
The FDA product code for Avoset Infusion Pump System is FRN.
相關臨床試驗
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相關器械（代碼：FRN）
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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