FDA 510(k)

集成式追赶自由注射泵系统

K号: K162613 · 2017-08-31

申请人Repro-Med Systems, Inc. Dba Rms Medical Products

决定日期2017-08-31

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

Integrated Catch-up Freedom Syringe Driver Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Repro-Med Systems, Inc. Dba Rms Medical Products. It received FDA 510(k) clearance on 2017-08-31 under 510(k) number K162613. 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 Integrated Catch-up Freedom Syringe Driver Infusion System?

Integrated Catch-up Freedom Syringe Driver Infusion System is a medical device that received FDA 510(k) clearance on 2017-08-31. The listed applicant is Repro-Med Systems, Inc. Dba Rms Medical Products. The 510(k) number is K162613.

When did Integrated Catch-up Freedom Syringe Driver Infusion System receive FDA 510(k) clearance?

Integrated Catch-up Freedom Syringe Driver Infusion System received FDA 510(k) clearance on 2017-08-31, under 510(k) number K162613.

Who is the listed applicant for Integrated Catch-up Freedom Syringe Driver Infusion System?

The FDA 510(k) record lists Repro-Med Systems, Inc. Dba Rms Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Integrated Catch-up Freedom Syringe Driver Infusion System?

The FDA product code for Integrated Catch-up Freedom Syringe Driver Infusion System is FRN.

列明Repro-Med Systems, Inc. Dba Rms Medical Products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。

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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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