免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据,仅供一般参考,不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

MindMotionPRO

K号: K162748 · 2017-04-24

申请人Mindmaze SA
决定日期2017-04-24
产品代码LXJ
咨询委员会PM 请注意,由于您没有提供具体的医疗设备监管文本,我无法进行翻译。请提供具体的文本内容,以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

MindMotionPRO is the device name listed in this FDA 510(k) record. The listed applicant is Mindmaze SA. It received FDA 510(k) clearance on 2017-04-24 under 510(k) number K162748. The device is classified under product code LXJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MindMotionPRO?

MindMotionPRO is a medical device that received FDA 510(k) clearance on 2017-04-24. The listed applicant is Mindmaze SA. The 510(k) number is K162748.

When did MindMotionPRO receive FDA 510(k) clearance?

MindMotionPRO received FDA 510(k) clearance on 2017-04-24, under 510(k) number K162748.

Who is the listed applicant for MindMotionPRO?

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

What is the FDA product code for MindMotionPRO?

The FDA product code for MindMotionPRO is LXJ.

相关临床试验

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。

列明Mindmaze SA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。

相关器械(代码:LXJ)

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

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。

↑