泵,輸注,植入式,可程式化
PMA 核准號:P800036 · 2020-02-07
廣告
決定日期2020-02-07
PMA 編號P800036
產品代碼LKK
器械分類3 類
醫療專科U
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。
器材摘要
Pump, infusion, implanted, programmable is the device name listed in this FDA 510(k) record. The listed applicant is Intera Oncology. It received FDA 510(k) clearance on 2020-02-07. The device is classified under product code LKK. It was reviewed by the HO advisory panel.
常見問題
What is the Pump, infusion, implanted, programmable?
Pump, infusion, implanted, programmable is a medical device that received FDA 510(k) clearance on 2020-02-07. The listed applicant is Intera Oncology.
When did Pump, infusion, implanted, programmable receive FDA 510(k) clearance?
The clearance date for Pump, infusion, implanted, programmable can be found in the official FDA records.
誰是泵、輸注、植入式、可編程設備的登記申請人?
The FDA 510(k) record lists Intera Oncology as the applicant. This does not by itself establish the device manufacturer.
FDA產品代碼為泵、輸注、植入式、可編程的什麼?
FDA產品代碼對於泵、輸注、植入式、可編程的產品為LKK。
相關臨床試驗
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。
廣告