FDA 510(k)

Shield 系统

K号: K222625 · 2022-09-30

决定日期2022-09-30

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

Shield System is the device name listed in this FDA 510(k) record. The listed applicant is Radiaction , Ltd.. It received FDA 510(k) clearance on 2022-09-30 under 510(k) number K222625. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Shield System?

Shield System is a medical device that received FDA 510(k) clearance on 2022-09-30. The listed applicant is Radiaction , Ltd.. The 510(k) number is K222625.

When did Shield System receive FDA 510(k) clearance?

Shield System received FDA 510(k) clearance on 2022-09-30, under 510(k) number K222625.

Who is the listed applicant for Shield System?

FDA 510(k)记录将Radiaction Ltd.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Shield System?

The FDA product code for Shield System is OWB.

列明Radiaction , 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。

K260607防护系统（西门子30x40）K212159Shield 系统

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。