FDA 510(k)

RemunityPRO™ 泵用於Remodulin®（treprostinil）注射劑

K 號：K250357 · 2025-03-11

決定日期2025-03-11

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

RemunityPRO™ Pump for Remodulin® (treprostinil) Injection is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research & Development Corp.. It received FDA 510(k) clearance on 2025-03-11 under 510(k) number K250357. 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 RemunityPRO™ Pump for Remodulin® (treprostinil) Injection?

RemunityPRO™ Pump for Remodulin® (treprostinil) Injection is a medical device that received FDA 510(k) clearance on 2025-03-11. The listed applicant is Deka Research & Development Corp.. The 510(k) number is K250357.

When did RemunityPRO™ Pump for Remodulin® (treprostinil) Injection receive FDA 510(k) clearance?

RemunityPRO™ Pump for Remodulin® (treprostinil) Injection received FDA 510(k) clearance on 2025-03-11, under 510(k) number K250357.

Who is the listed applicant for RemunityPRO™ Pump for Remodulin® (treprostinil) Injection?

The FDA 510(k) record lists Deka Research & Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RemunityPRO™ Pump for Remodulin® (treprostinil) Injection?

The FDA product code for RemunityPRO™ Pump for Remodulin® (treprostinil) Injection is FRN.

其他以 Deka Research & Development Corp. 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。

K250930twiist系統 K241736Remunity 2.0 泵用於Remodulin（treprostinil）注射劑 K243354Remunity 系統 K172601下一代iBOT

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

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