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FDA 510(k)

ClariSIGMAM

K号: K203785 · 2021-09-10

申请人Claripi, Inc.
决定日期2021-09-10
产品代码QIH
咨询委员会RA
决定实质等同

器械摘要

ClariSIGMAM is the device name listed in this FDA 510(k) record. The listed applicant is Claripi, Inc.. It received FDA 510(k) clearance on 2021-09-10 under 510(k) number K203785. 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 ClariSIGMAM?

ClariSIGMAM is a medical device that received FDA 510(k) clearance on 2021-09-10. The listed applicant is Claripi, Inc.. The 510(k) number is K203785.

When did ClariSIGMAM receive FDA 510(k) clearance?

ClariSIGMAM received FDA 510(k) clearance on 2021-09-10, under 510(k) number K203785.

Who is the listed applicant for ClariSIGMAM?

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

What is the FDA product code for ClariSIGMAM?

The FDA product code for ClariSIGMAM is QIH.

相关临床试验

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列明Claripi, 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。

相关器械(代码:QIH)

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。

官方来源

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