FDA 510(k)

Agilia SP 注射系統, Agilia SP MC WIFI 注射泵, Agilia Link, Agilia Duo, Agilia USB 線

K 號：K210074 · 2022-03-01

決定日期2022-03-01

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

Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Kabi AG. It received FDA 510(k) clearance on 2022-03-01 under 510(k) number K210074. 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 Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable?

Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable is a medical device that received FDA 510(k) clearance on 2022-03-01. The listed applicant is Fresenius Kabi AG. The 510(k) number is K210074.

When did Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable receive FDA 510(k) clearance?

Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable received FDA 510(k) clearance on 2022-03-01, under 510(k) number K210074.

Who is the listed applicant for Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable?

The FDA 510(k) record lists Fresenius Kabi AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable?

The FDA product code for Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable is FRN.

其他以 Fresenius Kabi AG 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。

K251139KabiHelp® 一次性；KabiHelp® 先進加 K212445freeflex+ 轉接器 K210075Vigilant軟體套件 – Vigilant Master 医療設備 K210073Agilia VP 注射系統, Agilia VP MC WIFI 注射泵, Volumat Lines 管理套件, Agilia Link, Agilia Duo K210089CATSmart，自動血液處理自輸血系統 K200530AMICUS 分離系統

查看所有 11 項裝置 →

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。

K253703RemunityPRO+ 泵用於Remodulin®（treprostinil）注射劑Deka R&D Corp K252015FreedomEdge 渗透系統；高流量 SubQ 鋒針組；精準流量管Koru Medical Systems, Inc.K251636Spectrum IQ 注射系統搭配 Dose IQ 安全軟體（3570009）Baxter Healthcare Corporation K251640SIGMA Spectrum 靜脈注射泵，配備主藥物圖書館Baxter Healthcare Corporation K242752Mridium 3870 MRI 輸液泵系統（3870）Iradimed Corporation K243855BD Alaris 靜脈輸注系統配Guardrails Suite MXCarefusion 303, Inc.

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。