FDA 510(k)

BD MAX CT/GC/TV, BD MAX 仪器

K号: K151589 · 2016-09-06

决定日期2016-09-06

产品代码OUY

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决定实质等同

器械摘要

BD MAX CT/GC/TV, BD MAX INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2016-09-06 under 510(k) number K151589. The device is classified under product code OUY. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BD MAX CT/GC/TV, BD MAX INSTRUMENT?

BD MAX CT/GC/TV, BD MAX INSTRUMENT is a medical device that received FDA 510(k) clearance on 2016-09-06. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K151589.

When did BD MAX CT/GC/TV, BD MAX INSTRUMENT receive FDA 510(k) clearance?

BD MAX CT/GC/TV, BD MAX INSTRUMENT received FDA 510(k) clearance on 2016-09-06, under 510(k) number K151589.

Who is the listed applicant for BD MAX CT/GC/TV, BD MAX INSTRUMENT?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD MAX CT/GC/TV, BD MAX INSTRUMENT?

The FDA product code for BD MAX CT/GC/TV, BD MAX INSTRUMENT is OUY.

列明Becton, Dickinson and Company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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