FDA 510(k)

Ceevra Reveal 3+

K号: K243933 · 2025-03-04

决定日期2025-03-04

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 2025-03-04 under 510(k) number K243933. 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 2025-03-04. The listed applicant is Ceevra, Inc.. The 510(k) number is K243933.

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

Ceevra Reveal 3+ received FDA 510(k) clearance on 2025-03-04, under 510(k) number K243933.

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 K233568Ceevra Reveal 3+K222676Ceevra Reveal 3 K173274Ceevra Reveal 2.0 K171356Clarity Reveal

官方来源

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