FDA 510(k)

iCare ALTIUS CW

K号: K234076 · 2024-08-22

决定日期2024-08-22

产品代码NFJ

咨询委员会RA

决定实质等同

器械摘要

iCare ALTIUS CW is the device name listed in this FDA 510(k) record. The listed applicant is Centervue S.P.A.. It received FDA 510(k) clearance on 2024-08-22 under 510(k) number K234076. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the iCare ALTIUS CW?

iCare ALTIUS CW is a medical device that received FDA 510(k) clearance on 2024-08-22. The listed applicant is Centervue S.P.A.. The 510(k) number is K234076.

When did iCare ALTIUS CW receive FDA 510(k) clearance?

iCare ALTIUS CW received FDA 510(k) clearance on 2024-08-22, under 510(k) number K234076.

Who is the listed applicant for iCare ALTIUS CW?

The FDA 510(k) record lists Centervue S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iCare ALTIUS CW?

The FDA product code for iCare ALTIUS CW is NFJ.

列明Centervue S.P.A.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。

K243504MAIA (AHMACME001)K213705DRSplus K211328EIDON FA，EIDON，EIDON AF，EIDON UWFL K192113DRSplus K180526EIDON FA K180293Retia 2

查看所有 8 个设备 →

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。