FDA 510(k)

Sapphire 输液泵, Sapphire 注射器套装

K号: K192860 · 2020-11-19

决定日期2020-11-19

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

Sapphire Infusion Pump, Sapphire administration sets is the device name listed in this FDA 510(k) record. The listed applicant is Q Core Medical , Ltd.. It received FDA 510(k) clearance on 2020-11-19 under 510(k) number K192860. 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 Sapphire Infusion Pump, Sapphire administration sets?

Sapphire Infusion Pump, Sapphire administration sets is a medical device that received FDA 510(k) clearance on 2020-11-19. The listed applicant is Q Core Medical , Ltd.. The 510(k) number is K192860.

When did Sapphire Infusion Pump, Sapphire administration sets receive FDA 510(k) clearance?

Sapphire Infusion Pump, Sapphire administration sets received FDA 510(k) clearance on 2020-11-19, under 510(k) number K192860.

Who is the listed applicant for Sapphire Infusion Pump, Sapphire administration sets?

The FDA 510(k) record lists Q Core Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sapphire Infusion Pump, Sapphire administration sets?

The FDA product code for Sapphire Infusion Pump, Sapphire administration sets is FRN.

列明Q Core Medical , Ltd.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。

K161667Sapphire 输液泵

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。

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官方来源

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