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FDA 510(k)

LifeFlow 緊急輸液裝置（LifeFlow 裝置）

K 號：K153731 · 2016-08-25

申請人410 Medical Innovation, LLC
決定日期2016-08-25
產品代碼FPA
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

LifeFlow Rapid Infusion Device (LifeFlow Device) is the device name listed in this FDA 510(k) record. The listed applicant is 410 Medical Innovation, LLC. It received FDA 510(k) clearance on 2016-08-25 under 510(k) number K153731. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LifeFlow Rapid Infusion Device (LifeFlow Device)?

LifeFlow Rapid Infusion Device (LifeFlow Device) is a medical device that received FDA 510(k) clearance on 2016-08-25. The listed applicant is 410 Medical Innovation, LLC. The 510(k) number is K153731.

When did LifeFlow Rapid Infusion Device (LifeFlow Device) receive FDA 510(k) clearance?

LifeFlow Rapid Infusion Device (LifeFlow Device) received FDA 510(k) clearance on 2016-08-25, under 510(k) number K153731.

Who is the listed applicant for LifeFlow Rapid Infusion Device (LifeFlow Device)?

The FDA 510(k) record lists 410 Medical Innovation, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LifeFlow Rapid Infusion Device (LifeFlow Device)?

The FDA product code for LifeFlow Rapid Infusion Device (LifeFlow Device) is FPA.

相關臨床試驗

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相關器械（代碼：FPA）

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。

K254123Ecomed 一次性注射用藥物輸注套件Ecomed Solutions, LLCK261530iiSure 靜脈輸注套件Deka Research and DevelopmentK252543AMSafe 藥物輸注套件 (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath 火飛無針連接器 IT (9005)Puracath Medical, Inc.K251257nSet+ 稳定組 [6426733]; nSet+ 稳定組搭配 nSyte 非針刺連接器 (NFC) [6426731]; nSyte 非針刺連接器 (NFC) [6426727]Np MedicalK250325BD Alaris 泵輸注套件Carefusion (Bd)

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