里奧藥品由瓶至袋重組設備
K 號：K192154 · 2020-04-20
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申請人Icu Medical
決定日期2020-04-20
產品代碼LHI
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
Rio Vial-to-Bag Drug Reconstitution Device is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical. It received FDA 510(k) clearance on 2020-04-20 under 510(k) number K192154. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Rio Vial-to-Bag Drug Reconstitution Device?
Rio Vial-to-Bag Drug Reconstitution Device is a medical device that received FDA 510(k) clearance on 2020-04-20. The listed applicant is Icu Medical. The 510(k) number is K192154.
When did Rio Vial-to-Bag Drug Reconstitution Device receive FDA 510(k) clearance?
Rio Vial-to-Bag Drug Reconstitution Device received FDA 510(k) clearance on 2020-04-20, under 510(k) number K192154.
Who is the listed applicant for Rio Vial-to-Bag Drug Reconstitution Device?
The FDA 510(k) record lists Icu Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Rio Vial-to-Bag Drug Reconstitution Device?
The FDA product code for Rio Vial-to-Bag Drug Reconstitution Device is LHI.
相關臨床試驗
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其他以 Icu Medical 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。
相關器械（代碼：LHI）
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
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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