FDA 510(k)

Arterys MICA

K号: K192437 · 2020-03-25

决定日期2020-03-25

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

Arterys MICA is the device name listed in this FDA 510(k) record. The listed applicant is Arterys, Inc.. It received FDA 510(k) clearance on 2020-03-25 under 510(k) number K192437. 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 Arterys MICA?

Arterys MICA is a medical device that received FDA 510(k) clearance on 2020-03-25. The listed applicant is Arterys, Inc.. The 510(k) number is K192437.

When did Arterys MICA receive FDA 510(k) clearance?

Arterys MICA received FDA 510(k) clearance on 2020-03-25, under 510(k) number K192437.

Who is the listed applicant for Arterys MICA?

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

What is the FDA product code for Arterys MICA?

The FDA product code for Arterys MICA is QIH.

列明Arterys, 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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