FDA 510(k)

MRidium 3860+ MRI输液泵/监控系统

K号: K143369 · 2016-12-15

决定日期2016-12-15

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

MRidium 3860+ MRI infusion Pump/ Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Iradimed Corporation. It received FDA 510(k) clearance on 2016-12-15 under 510(k) number K143369. 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 MRidium 3860+ MRI infusion Pump/ Monitoring System?

MRidium 3860+ MRI infusion Pump/ Monitoring System is a medical device that received FDA 510(k) clearance on 2016-12-15. The listed applicant is Iradimed Corporation. The 510(k) number is K143369.

When did MRidium 3860+ MRI infusion Pump/ Monitoring System receive FDA 510(k) clearance?

MRidium 3860+ MRI infusion Pump/ Monitoring System received FDA 510(k) clearance on 2016-12-15, under 510(k) number K143369.

Who is the listed applicant for MRidium 3860+ MRI infusion Pump/ Monitoring System?

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

What is the FDA product code for MRidium 3860+ MRI infusion Pump/ Monitoring System?

The FDA product code for MRidium 3860+ MRI infusion Pump/ Monitoring System is FRN.

列明Iradimed Corporation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。

K242752MRidium 3870 MRI输液泵系统（3870）K1809033880 MRI 患者监护系统 K1829003880 MRI 患者监护系统 K1722003880 MRI 患者监护系统

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 Corp K252015FreedomEdge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 Corporation K251640SIGMA Spectrum 输液泵带主药物库Baxter Healthcare Corporation K242752MRidium 3870 MRI输液泵系统（3870）Iradimed Corporation K243855BD Alaris 输液系统带Guardrails Suite MXCarefusion 303, Inc.

官方来源

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