FDA 510(k)

Plum Duo™ 靜脈輸注系統

K 號：K223607 · 2023-08-24

決定日期2023-08-24

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

Plum Duo™ Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 2023-08-24 under 510(k) number K223607. 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 Plum Duo™ Infusion System?

Plum Duo™ Infusion System is a medical device that received FDA 510(k) clearance on 2023-08-24. The listed applicant is Icu Medical, Inc.. The 510(k) number is K223607.

When did Plum Duo™ Infusion System receive FDA 510(k) clearance?

Plum Duo™ Infusion System received FDA 510(k) clearance on 2023-08-24, under 510(k) number K223607.

Who is the listed applicant for Plum Duo™ Infusion System?

The FDA 510(k) record lists Icu Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Plum Duo™ Infusion System?

The FDA product code for Plum Duo™ Infusion System is FRN.

其他以 Icu Medical, Inc. 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。

K252130生命盾輸液安全軟體套件 K252006OTTO™ 消毒帽 K251980ClaveQS™ 袋 K250616Clave™ 中立移位無針連接器 K242115Plum Duo™精準靜脈輸液泵 K242114Plum Solo™精準靜脈輸液泵

查看所有 14 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。