FDA 510(k)

Nustat XR

K号: K160578 · 2016-06-29

决定日期2016-06-29

产品代码QSY

决定实质等同

器械摘要

Nustat XR is the device name listed in this FDA 510(k) record. The listed applicant is Beeken Biomedical, LLC. It received FDA 510(k) clearance on 2016-06-29 under 510(k) number K160578. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

常见问题

What is the Nustat XR?

Nustat XR is a medical device that received FDA 510(k) clearance on 2016-06-29. The listed applicant is Beeken Biomedical, LLC. The 510(k) number is K160578.

When did Nustat XR receive FDA 510(k) clearance?

Nustat XR received FDA 510(k) clearance on 2016-06-29, under 510(k) number K160578.

Who is the listed applicant for Nustat XR?

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

What is the FDA product code for Nustat XR?

The FDA product code for Nustat XR is QSY.

列明Beeken Biomedical, 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。

K183190NuStat

相关器械（代码：QSY）

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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