FDA 510(k)

三联进化

K号: K181166 · 2019-07-18

决定日期2019-07-18

产品代码CBK

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

Trilogy Evo is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2019-07-18 under 510(k) number K181166. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Trilogy Evo?

Trilogy Evo is a medical device that received FDA 510(k) clearance on 2019-07-18. The listed applicant is Respironics, Inc.. The 510(k) number is K181166.

When did Trilogy Evo receive FDA 510(k) clearance?

Trilogy Evo received FDA 510(k) clearance on 2019-07-18, under 510(k) number K181166.

Who is the listed applicant for Trilogy Evo?

FDA 510(k)记录中列出Respironics, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Trilogy Evo?

The FDA product code for Trilogy Evo is CBK.

列明Respironics, 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。

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相关器械（代码：CBK）

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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