免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

Remunity 2.0 泵用於Remodulin（treprostinil）注射劑

K 號：K241736 · 2025-01-16

申請人Deka Research and Development Corp.
決定日期2025-01-16
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

Remunity 2.0 Pump for Remodulin (treprostinil) Injection is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research and Development Corp.. It received FDA 510(k) clearance on 2025-01-16 under 510(k) number K241736. 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 Remunity 2.0 Pump for Remodulin (treprostinil) Injection?

Remunity 2.0 Pump for Remodulin (treprostinil) Injection is a medical device that received FDA 510(k) clearance on 2025-01-16. The listed applicant is Deka Research and Development Corp.. The 510(k) number is K241736.

When did Remunity 2.0 Pump for Remodulin (treprostinil) Injection receive FDA 510(k) clearance?

Remunity 2.0 Pump for Remodulin (treprostinil) Injection received FDA 510(k) clearance on 2025-01-16, under 510(k) number K241736.

Who is the listed applicant for Remunity 2.0 Pump for Remodulin (treprostinil) Injection?

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

What is the FDA product code for Remunity 2.0 Pump for Remodulin (treprostinil) Injection?

The FDA product code for Remunity 2.0 Pump for Remodulin (treprostinil) Injection is FRN.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Deka Research and 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K250357RemunityPRO™ 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 CorpK252015FreedomEdge 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 CorporationK251640SIGMA Spectrum 靜脈注射泵，配備主藥物圖書館Baxter Healthcare CorporationK242752Mridium 3870 MRI 輸液泵系統（3870）Iradimed CorporationK243855BD 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。

↑