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FDA 510(k)

Plum 360™ 注射系统，带 MedNet/ Smart Card 即插即用模块

K号: K161469 · 2017-03-28

申请人Hospira, Inc.
决定日期2017-03-28
产品代码FRN
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。
决定实质等同

器械摘要

Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module is the device name listed in this FDA 510(k) record. The listed applicant is Hospira, Inc.. It received FDA 510(k) clearance on 2017-03-28 under 510(k) number K161469. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module?

Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module is a medical device that received FDA 510(k) clearance on 2017-03-28. The listed applicant is Hospira, Inc.. The 510(k) number is K161469.

When did Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module receive FDA 510(k) clearance?

Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module received FDA 510(k) clearance on 2017-03-28, under 510(k) number K161469.

Who is the listed applicant for Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module?

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

What is the FDA product code for Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module?

The FDA product code for Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module is FRN.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Hospira, Inc.为申报人的其他记录

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。

K161036Hospira 扩展套件，Hospira 主要套件K160492Hospira Sapphire 套件K160870Hospira 注射器K143612LifeCare PCA 输液系统

相关器械（代码：FRN）

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。

K253703RemunityPRO+ Remodulin®（曲前列尼尔）注射泵Deka R&D CorpK252015FreedomEdge输液系统；高流量SubQ注射针套装；精确流量管Koru Medical Systems, Inc.K251636Spectrum IQ 注射系统，配备剂量 IQ 安全软件（3570009）Baxter Healthcare CorporationK251640SIGMA Spectrum 输液泵带主药物库Baxter Healthcare CorporationK242752MRidium 3870 MRI输液泵系统（3870）Iradimed CorporationK243855BD Alaris 输液系统带Guardrails Suite MXCarefusion 303, Inc.

官方来源

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