FDA 510(k)

Blueprint 混合现实系统

K号: K222510 · 2023-01-20

决定日期2023-01-20

产品代码OLO

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Blueprint Mixed Reality system is the device name listed in this FDA 510(k) record. The listed applicant is Tornier S.A.S.. It received FDA 510(k) clearance on 2023-01-20 under 510(k) number K222510. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Blueprint Mixed Reality system?

Blueprint Mixed Reality system is a medical device that received FDA 510(k) clearance on 2023-01-20. The listed applicant is Tornier S.A.S.. The 510(k) number is K222510.

When did Blueprint Mixed Reality system receive FDA 510(k) clearance?

Blueprint Mixed Reality system received FDA 510(k) clearance on 2023-01-20, under 510(k) number K222510.

Who is the listed applicant for Blueprint Mixed Reality system?

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

What is the FDA product code for Blueprint Mixed Reality system?

The FDA product code for Blueprint Mixed Reality system is OLO.

列明Tornier S.A.S.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。

K232265BLUEPRINT™ 患者专用器械 K203315BLUEPRINT™ 患者专用器械 K190521Aequalis Ascend Flex肩部系统 K162800BLUEPRINT 患者专用器械 K161789BLUEPRINT 患者专用器械 K153452Salto XT，Salto Talaris

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。