FDA 510(k)

CytoCore

K号: K200278 · 2020-03-31

决定日期2020-03-31

产品代码KNW

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决定实质等同

器械摘要

CytoCore is the device name listed in this FDA 510(k) record. The listed applicant is Praxis Medical, LLC. It received FDA 510(k) clearance on 2020-03-31 under 510(k) number K200278. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CytoCore?

CytoCore is a medical device that received FDA 510(k) clearance on 2020-03-31. The listed applicant is Praxis Medical, LLC. The 510(k) number is K200278.

When did CytoCore receive FDA 510(k) clearance?

CytoCore received FDA 510(k) clearance on 2020-03-31, under 510(k) number K200278.

Who is the listed applicant for CytoCore?

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

What is the FDA product code for CytoCore?

The FDA product code for CytoCore is KNW.

列明Praxis Medical, LLC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。

K230778EndoCore

相关器械（代码：KNW）

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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