FDA 510(k)

ClearPoint Maestro 脑模型

K号: K213645 · 2022-08-08

决定日期2022-08-08

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

ClearPoint Maestro Brain Model is the device name listed in this FDA 510(k) record. The listed applicant is ClearPoint Neuro, Inc.. It received FDA 510(k) clearance on 2022-08-08 under 510(k) number K213645. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ClearPoint Maestro Brain Model?

ClearPoint Maestro Brain Model is a medical device that received FDA 510(k) clearance on 2022-08-08. The listed applicant is ClearPoint Neuro, Inc.. The 510(k) number is K213645.

When did ClearPoint Maestro Brain Model receive FDA 510(k) clearance?

ClearPoint Maestro Brain Model received FDA 510(k) clearance on 2022-08-08, under 510(k) number K213645.

Who is the listed applicant for ClearPoint Maestro Brain Model?

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

What is the FDA product code for ClearPoint Maestro Brain Model?

The FDA product code for ClearPoint Maestro Brain Model is QIH.

列明ClearPoint Neuro, 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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