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FDA 510(k)

CO2旁路模块

K号: K192488 · 2020-05-22

决定日期2020-05-22
产品代码CCK
咨询委员会AN 请注意,由于您没有提供完整的医疗设备监管文本,我无法提供完整的翻译。如果您能提供完整的文本,我将很乐意为您翻译。
决定实质等同

器械摘要

CO2 Sidestream Module is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Kingst Commercial & Trade Co., Ltd.. It received FDA 510(k) clearance on 2020-05-22 under 510(k) number K192488. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CO2 Sidestream Module?

CO2 Sidestream Module is a medical device that received FDA 510(k) clearance on 2020-05-22. The listed applicant is Beijing Kingst Commercial & Trade Co., Ltd.. The 510(k) number is K192488.

When did CO2 Sidestream Module receive FDA 510(k) clearance?

CO2 Sidestream Module received FDA 510(k) clearance on 2020-05-22, under 510(k) number K192488.

Who is the listed applicant for CO2 Sidestream Module?

The FDA 510(k) record lists Beijing Kingst Commercial & Trade Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO2 Sidestream Module?

The FDA product code for CO2 Sidestream Module is CCK.

相关临床试验

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列明Beijing Kingst Commercial & Trade Co., 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。

相关器械(代码:CCK)

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。

官方来源

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