FDA 510(k)

Perfect PFE

K号: K191312 · 2019-11-01

决定日期2019-11-01

产品代码KPI

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决定实质等同

器械摘要

Perfect PFE is the device name listed in this FDA 510(k) record. The listed applicant is Tenscare, Ltd.. It received FDA 510(k) clearance on 2019-11-01 under 510(k) number K191312. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Perfect PFE?

Perfect PFE is a medical device that received FDA 510(k) clearance on 2019-11-01. The listed applicant is Tenscare, Ltd.. The 510(k) number is K191312.

When did Perfect PFE receive FDA 510(k) clearance?

Perfect PFE received FDA 510(k) clearance on 2019-11-01, under 510(k) number K191312.

Who is the listed applicant for Perfect PFE?

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

What is the FDA product code for Perfect PFE?

The FDA product code for Perfect PFE is KPI.

列明Tenscare, 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。

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相关器械（代码：KPI）

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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