FDA 510(k)

Tenex Health TX系统

K号: K153299 · 2016-03-03

决定日期2016-03-03

产品代码LFL

决定实质等同

器械摘要

Tenex Health TX System is the device name listed in this FDA 510(k) record. The listed applicant is Tenex Health, Inc.. It received FDA 510(k) clearance on 2016-03-03 under 510(k) number K153299. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

常见问题

What is the Tenex Health TX System?

Tenex Health TX System is a medical device that received FDA 510(k) clearance on 2016-03-03. The listed applicant is Tenex Health, Inc.. The 510(k) number is K153299.

When did Tenex Health TX System receive FDA 510(k) clearance?

Tenex Health TX System received FDA 510(k) clearance on 2016-03-03, under 510(k) number K153299.

Who is the listed applicant for Tenex Health TX System?

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

What is the FDA product code for Tenex Health TX System?

The FDA product code for Tenex Health TX System is LFL.

列明Tenex Health, 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。

K181367Tenex Health TX系统带TXP微尖

相关器械（代码：LFL）

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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