FDA 510(k)

HealthCXR

K号: K192320 · 2019-11-26

决定日期2019-11-26

产品代码QFM

咨询委员会RA

决定实质等同

器械摘要

HealthCXR is the device name listed in this FDA 510(k) record. The listed applicant is Zebra Medical Vision, Ltd.. It received FDA 510(k) clearance on 2019-11-26 under 510(k) number K192320. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HealthCXR?

HealthCXR is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is Zebra Medical Vision, Ltd.. The 510(k) number is K192320.

When did HealthCXR receive FDA 510(k) clearance?

HealthCXR received FDA 510(k) clearance on 2019-11-26, under 510(k) number K192320.

Who is the listed applicant for HealthCXR?

The FDA 510(k) record lists Zebra Medical Vision, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HealthCXR?

The FDA product code for HealthCXR is QFM.

列明Zebra Medical Vision, Ltd.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。

K211803HealthPPT K210085HealthCCSng K202487HealthJOINT K200905HealthMammo K192901HealthVCF K190424HealthICH

查看所有 9 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。