LifeFlow 快速输液装置（LifeFlow 设备）
K号: K153731 · 2016-08-25
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决定日期2016-08-25
产品代码FPA
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
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器械摘要
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.
常见问题
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.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：FPA）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K254123Ecomed 一次性给药套装Ecomed Solutions, LLCK261530iiSure 静脉输液器Deka Research and DevelopmentK252543AMSafe 注射器套装（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 Firefly 无针连接器 IT (9005)Puracath Medical, Inc.K251257nSet+ 稳定装置 [6426733]; nSet+ 稳定装置带 nSyte 无针连接器 (NFC) [6426731]; nSyte 无针连接器 (NFC) [6426727]Np MedicalK250325BD Alaris 泵输液套装Carefusion (Bd)
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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