FDA 510(k)

Cleerly LABS (v2.0)

K号: K242338 · 2025-03-07

决定日期2025-03-07

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

Cleerly LABS (v2.0) is the device name listed in this FDA 510(k) record. The listed applicant is Cleerly, Inc.. It received FDA 510(k) clearance on 2025-03-07 under 510(k) number K242338. 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 Cleerly LABS (v2.0)?

Cleerly LABS (v2.0) is a medical device that received FDA 510(k) clearance on 2025-03-07. The listed applicant is Cleerly, Inc.. The 510(k) number is K242338.

When did Cleerly LABS (v2.0) receive FDA 510(k) clearance?

Cleerly LABS (v2.0) received FDA 510(k) clearance on 2025-03-07, under 510(k) number K242338.

Who is the listed applicant for Cleerly LABS (v2.0)?

FDA 510(k)记录中列出Cleerly, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Cleerly LABS (v2.0)?

The FDA product code for Cleerly LABS (v2.0) is QIH.

列明Cleerly, 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。

K261210Cleerly 斑块 K260588Cleerly 实验室 K231335Cleerly ISCHEMIA K202280Cleerly Labs v2.0 K190868Cleerly Labs

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。