FDA 510(k)

Z-DOSE29

K号: K170273 · 2017-04-28

决定日期2017-04-28

产品代码JAK

咨询委员会RA

决定实质等同

器械摘要

Z-DOSE29 is the device name listed in this FDA 510(k) record. The listed applicant is Zetta Medical Technologies, LLC. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K170273. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Z-DOSE29?

Z-DOSE29 is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Zetta Medical Technologies, LLC. The 510(k) number is K170273.

When did Z-DOSE29 receive FDA 510(k) clearance?

Z-DOSE29 received FDA 510(k) clearance on 2017-04-28, under 510(k) number K170273.

Who is the listed applicant for Z-DOSE29?

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

What is the FDA product code for Z-DOSE29?

The FDA product code for Z-DOSE29 is JAK.

列明Zetta Medical Technologies, 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。

K172768ZOOM K160852Zia医疗设备监管文本翻译： Zia医疗设备符合FDA（美国食品药品监督管理局）510(k)和PMA（上市前批准）要求，NCT（临床试验注册号）为XXXXX，PMID（PubMed ID）为XXXXX。请访问以下网址获取更多信息：http://www.example.com/medical-device-regulatory-v1

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Zetta Medical Technologies, LLC为申报人的其他记录

相关器械（代码：JAK）

官方来源