劑量IQ安全軟體
K 號：K230665 · 2024-03-29
廣告
決定日期2024-03-29
產品代碼PHC
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
Dose IQ Safety Software is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2024-03-29 under 510(k) number K230665. The device is classified under product code PHC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Dose IQ Safety Software?
Dose IQ Safety Software is a medical device that received FDA 510(k) clearance on 2024-03-29. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K230665.
When did Dose IQ Safety Software receive FDA 510(k) clearance?
Dose IQ Safety Software received FDA 510(k) clearance on 2024-03-29, under 510(k) number K230665.
Who is the listed applicant for Dose IQ Safety Software?
The FDA 510(k) record lists Baxter Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dose IQ Safety Software?
The FDA product code for Dose IQ Safety Software is PHC.
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。
其他以 Baxter Healthcare 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。
相關器械（代碼：PHC）
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。
K252130生命盾輸液安全軟體套件Icu Medical, Inc.K243062BD Intelliport 系統; BD Intelliport 閱讀器 (516230); BD Intelliport 感應器 (516229); BD Intelliport 網關 (516232); BD Intelliport 裝置 (516233); BD Intelliport 充電器 (516231)Becton DickinsonK242117生命盾輸液安全軟體套件Icu Medical, Inc.K223606LifeShield™ 靜脈輸注安全軟體套件Icu Medical, Inc.K211124劑量IQ安全軟體Baxter Healthcare CorporationK210075Vigilant軟體套件 – Vigilant Master 医療設備Fresenius Kabi AG
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