FDA 510(k)

Brainance MD

K号: K202808 · 2021-10-14

申请人Advantis Medical Imaging Single Member P.C.

决定日期2021-10-14

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

Brainance MD is the device name listed in this FDA 510(k) record. The listed applicant is Advantis Medical Imaging Single Member P.C.. It received FDA 510(k) clearance on 2021-10-14 under 510(k) number K202808. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Brainance MD?

Brainance MD is a medical device that received FDA 510(k) clearance on 2021-10-14. The listed applicant is Advantis Medical Imaging Single Member P.C.. The 510(k) number is K202808.

When did Brainance MD receive FDA 510(k) clearance?

Brainance MD received FDA 510(k) clearance on 2021-10-14, under 510(k) number K202808.

Who is the listed applicant for Brainance MD?

The FDA 510(k) record lists Advantis Medical Imaging Single Member P.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Brainance MD?

The FDA product code for Brainance MD is LLZ.

列明Advantis Medical Imaging Single Member P.C.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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