FDA 510(k)

BrainView QEEG 软件

K号: K212684 · 2023-01-28

决定日期2023-01-28

产品代码OLU

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决定实质等同

器械摘要

BrainView QEEG Software is the device name listed in this FDA 510(k) record. The listed applicant is Medeia, Inc.. It received FDA 510(k) clearance on 2023-01-28 under 510(k) number K212684. The device is classified under product code OLU. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BrainView QEEG Software?

BrainView QEEG Software is a medical device that received FDA 510(k) clearance on 2023-01-28. The listed applicant is Medeia, Inc.. The 510(k) number is K212684.

When did BrainView QEEG Software receive FDA 510(k) clearance?

BrainView QEEG Software received FDA 510(k) clearance on 2023-01-28, under 510(k) number K212684.

Who is the listed applicant for BrainView QEEG Software?

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

What is the FDA product code for BrainView QEEG Software?

The FDA product code for BrainView QEEG Software is OLU.

列明Medeia, Inc.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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