FDA 510(k)

BD MAX CTGCTV2, BD MAX 系统

K号: K182692 · 2019-01-08

决定日期2019-01-08

产品代码OUY

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决定实质等同

器械摘要

BD MAX CTGCTV2, BD MAX System 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 2019-01-08 under 510(k) number K182692. 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 CTGCTV2, BD MAX System?

BD MAX CTGCTV2, BD MAX System is a medical device that received FDA 510(k) clearance on 2019-01-08. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K182692.

When did BD MAX CTGCTV2, BD MAX System receive FDA 510(k) clearance?

BD MAX CTGCTV2, BD MAX System received FDA 510(k) clearance on 2019-01-08, under 510(k) number K182692.

Who is the listed applicant for BD MAX CTGCTV2, BD MAX System?

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 CTGCTV2, BD MAX System?

The FDA product code for BD MAX CTGCTV2, BD MAX System 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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