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FDA 510(k)

戰士血液及體液加熱器，戰士EXTREME血液及體液加熱器，戰士輕量血液及體液加熱器

K 號：K211800 · 2022-12-08

申請人Quality IN Flow , Ltd.
決定日期2022-12-08
產品代碼LGZ
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

Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer is the device name listed in this FDA 510(k) record. The listed applicant is Quality IN Flow , Ltd.. It received FDA 510(k) clearance on 2022-12-08 under 510(k) number K211800. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer?

Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer is a medical device that received FDA 510(k) clearance on 2022-12-08. The listed applicant is Quality IN Flow , Ltd.. The 510(k) number is K211800.

When did Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer receive FDA 510(k) clearance?

Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer received FDA 510(k) clearance on 2022-12-08, under 510(k) number K211800.

Who is the listed applicant for Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer?

The FDA 510(k) record lists Quality IN Flow , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer?

The FDA product code for Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer is LGZ.

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 Quality IN Flow , Ltd. 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。

K180154奇福血液及體液加溫器K171215奇福血液及體液加溫器K163708奇福血液及體液加溫器K150404奇福血液及體液加溫器

相關器械（代碼：LGZ）

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。

K262532NORMOFLO™ 灌洗液加熱組合及配件（IR-601、IR-501、IR-61、PL-61）ICU MedicalK260988°M加熱系統搭配°M工作站Mequ A/SK252636流體精簡系統The Surgical Company International B.V.K251733Fluido®空氣守護系統The Surgical Company International BV (As Tsc Life)K232107°M加溫系統Mequ A/SK211618Fluido 細胞與體液加熱系統The Surgical Company International B.V.

官方來源

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