FDA 510(k)

Hybrid3D

K号: K181468 · 2018-10-25

决定日期2018-10-25

产品代码KPS

咨询委员会RA

决定实质等同

器械摘要

Hybrid3D is the device name listed in this FDA 510(k) record. The listed applicant is Hermes Medical Solutions AB. It received FDA 510(k) clearance on 2018-10-25 under 510(k) number K181468. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Hybrid3D?

Hybrid3D is a medical device that received FDA 510(k) clearance on 2018-10-25. The listed applicant is Hermes Medical Solutions AB. The 510(k) number is K181468.

When did Hybrid3D receive FDA 510(k) clearance?

Hybrid3D received FDA 510(k) clearance on 2018-10-25, under 510(k) number K181468.

Who is the listed applicant for Hybrid3D?

FDA 510(k)记录显示Hermes Medical Solutions AB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 Hybrid3D?

The FDA product code for Hybrid3D is KPS.

列明Hermes Medical Solutions AB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。

K253835Affinity K252477Hybrid Viewer (00859873006240)K243919体素剂量学（00859873006226）K241364Hybrid Viewer (00859873006189)K202882Affinity K193152Affinity

查看所有 13 个设备 →

相关器械（代码：KPS）

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。

官方来源

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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。