FDA 510(k)

BrainInsight

K号: K202414 · 2021-01-07

决定日期2021-01-07

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

BrainInsight is the device name listed in this FDA 510(k) record. The listed applicant is Hyperfine Research, Inc.. It received FDA 510(k) clearance on 2021-01-07 under 510(k) number K202414. 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 BrainInsight?

BrainInsight is a medical device that received FDA 510(k) clearance on 2021-01-07. The listed applicant is Hyperfine Research, Inc.. The 510(k) number is K202414.

When did BrainInsight receive FDA 510(k) clearance?

BrainInsight received FDA 510(k) clearance on 2021-01-07, under 510(k) number K202414.

Who is the listed applicant for BrainInsight?

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

What is the FDA product code for BrainInsight?

The FDA product code for BrainInsight is LLZ.

列明Hyperfine Research, 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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