FDA 510(k)

Affinity

K号: K193152 · 2020-02-14

决定日期2020-02-14

产品代码KPS

咨询委员会RA

决定实质等同

器械摘要

Affinity 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 2020-02-14 under 510(k) number K193152. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

什么是亲和力？

Affinity is a medical device that received FDA 510(k) clearance on 2020-02-14. The listed applicant is Hermes Medical Solutions AB. The 510(k) number is K193152.

Affinity何时获得FDA 510(k)批准？

Affinity received FDA 510(k) clearance on 2020-02-14, under 510(k) number K193152.

Affinity的申请人名单是谁？

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。

Affinity的FDA产品代码是什么？

The FDA product code for Affinity 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 K191216Voxel剂量测量™ v1.0

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。