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)

轉向信號閥門無菌，轉向信號閥門大量無菌，轉向信號閥門帶歧管无菌，轉向信號閥門帶歧管大量無菌

K 號：K190539 · 2019-10-22

申請人Monumedical, LLC
決定日期2019-10-22
產品代碼FMG
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

TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Monumedical, LLC. It received FDA 510(k) clearance on 2019-10-22 under 510(k) number K190539. The device is classified under product code FMG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile?

TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile is a medical device that received FDA 510(k) clearance on 2019-10-22. The listed applicant is Monumedical, LLC. The 510(k) number is K190539.

When did TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile receive FDA 510(k) clearance?

TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile received FDA 510(k) clearance on 2019-10-22, under 510(k) number K190539.

Who is the listed applicant for TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile?

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

What is the FDA product code for TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile?

The FDA product code for TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile is FMG.

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

相關器械（代碼：FMG）

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。

K242255Qitexio® 4向止回閥 (QIT014)MedexK223499三通截止閥M/S Romsons InternationalK223175內血管輸注設備組合，含閥門和分配器Baxter Healthcare CorporationK211204SafePort™ 分流器（或閥門）Elcam Medical AcalK210516Clicky CrossYomura Technologies, Inc.K190489Elcam 阻斷釘及分配器Elcam Medical Acal

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。

↑