FDA 510(k)

Ceevra Reveal 3

K号: K222676 · 2023-04-25

决定日期2023-04-25

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

Ceevra Reveal 3 is the device name listed in this FDA 510(k) record. The listed applicant is Ceevra, Inc.. It received FDA 510(k) clearance on 2023-04-25 under 510(k) number K222676. 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 Ceevra Reveal 3?

Ceevra Reveal 3 is a medical device that received FDA 510(k) clearance on 2023-04-25. The listed applicant is Ceevra, Inc.. The 510(k) number is K222676.

When did Ceevra Reveal 3 receive FDA 510(k) clearance?

Ceevra Reveal 3 received FDA 510(k) clearance on 2023-04-25, under 510(k) number K222676.

Who is the listed applicant for Ceevra Reveal 3?

FDA 510(k)记录中列出Ceevra, 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 Ceevra Reveal 3?

The FDA product code for Ceevra Reveal 3 is QIH.

列明Ceevra, 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。

K261595Ceevra Reveal 4 K243933Ceevra Reveal 3+K233568Ceevra Reveal 3+K173274Ceevra Reveal 2.0 K171356Clarity Reveal

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。