FDA 510(k)

Bi-Flex Evo

K号: K182144 · 2018-09-07

决定日期2018-09-07

产品代码KNY

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决定实质等同

器械摘要

Bi-Flex Evo is the device name listed in this FDA 510(k) record. The listed applicant is Promepla Sam. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K182144. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Bi-Flex Evo?

Bi-Flex Evo is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Promepla Sam. The 510(k) number is K182144.

When did Bi-Flex Evo receive FDA 510(k) clearance?

Bi-Flex Evo received FDA 510(k) clearance on 2018-09-07, under 510(k) number K182144.

Who is the listed applicant for Bi-Flex Evo?

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

What is the FDA product code for Bi-Flex Evo?

The FDA product code for Bi-Flex Evo is KNY.

列明Promepla Sam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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官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

器械摘要

常见问题

列明Promepla Sam为申报人的其他记录

相关器械（代码：KNY）

官方来源