FDA 510(k)

奇福血液及體液加溫器

K 號：K150404 · 2016-06-23

決定日期2016-06-23

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

QiF 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 2016-06-23 under 510(k) number K150404. 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 QiF Blood and Fluid Warmer?

QiF Blood and Fluid Warmer is a medical device that received FDA 510(k) clearance on 2016-06-23. The listed applicant is Quality IN Flow , Ltd.. The 510(k) number is K150404.

When did QiF Blood and Fluid Warmer receive FDA 510(k) clearance?

QiF Blood and Fluid Warmer received FDA 510(k) clearance on 2016-06-23, under 510(k) number K150404.

Who is the listed applicant for QiF 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 QiF Blood and Fluid Warmer?

The FDA product code for QiF Blood and Fluid Warmer is LGZ.

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。

K211800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 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

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。

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官方來源

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