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FDA 510(k)

TrackX

K号: K173736 · 2018-02-28

决定日期2018-02-28
产品代码OWB
咨询委员会RA
决定实质等同

器械摘要

TrackX is the device name listed in this FDA 510(k) record. The listed applicant is Track X Technology, LLC. It received FDA 510(k) clearance on 2018-02-28 under 510(k) number K173736. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TrackX?

TrackX is a medical device that received FDA 510(k) clearance on 2018-02-28. The listed applicant is Track X Technology, LLC. The 510(k) number is K173736.

When did TrackX receive FDA 510(k) clearance?

TrackX received FDA 510(k) clearance on 2018-02-28, under 510(k) number K173736.

Who is the listed applicant for TrackX?

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

What is the FDA product code for TrackX?

The FDA product code for TrackX is OWB.

相关临床试验

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。

列明Track X Technology, 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。

相关器械(代码:OWB)

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。

官方来源

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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。

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