FDA 510(k)

cmAngio®（V1.6）

K号: K250754 · 2025-04-10

决定日期2025-04-10

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

cmAngio® (V1.6) is the device name listed in this FDA 510(k) record. The listed applicant is Curemetrix, Inc.. It received FDA 510(k) clearance on 2025-04-10 under 510(k) number K250754. 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 cmAngio® (V1.6)?

cmAngio® (V1.6) is a medical device that received FDA 510(k) clearance on 2025-04-10. The listed applicant is Curemetrix, Inc.. The 510(k) number is K250754.

When did cmAngio® (V1.6) receive FDA 510(k) clearance?

cmAngio® (V1.6) received FDA 510(k) clearance on 2025-04-10, under 510(k) number K250754.

Who is the listed applicant for cmAngio® (V1.6)?

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

What is the FDA product code for cmAngio® (V1.6)?

The FDA product code for cmAngio® (V1.6) is QIH.

列明Curemetrix, 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。

K260980cmAngio® V2.0 K232367cmAngio® V1.0 K183285cmTriage 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行准确的翻译。如果您能提供具体的文本内容，我将能够为您提供准确的翻译。

官方来源

在 FDA 数据库中查看 →

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。