FDA 510(k)

HORIZON TMS 疗法系统带导航

K号: K183376 · 2019-04-03

决定日期2019-04-03

产品代码OBP

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

HORIZON TMS Therapy System with Navigation is the device name listed in this FDA 510(k) record. The listed applicant is Magstim Company, Ltd.. It received FDA 510(k) clearance on 2019-04-03 under 510(k) number K183376. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HORIZON TMS Therapy System with Navigation?

HORIZON TMS Therapy System with Navigation is a medical device that received FDA 510(k) clearance on 2019-04-03. The listed applicant is Magstim Company, Ltd.. The 510(k) number is K183376.

When did HORIZON TMS Therapy System with Navigation receive FDA 510(k) clearance?

HORIZON TMS Therapy System with Navigation received FDA 510(k) clearance on 2019-04-03, under 510(k) number K183376.

Who is the listed applicant for HORIZON TMS Therapy System with Navigation?

The FDA 510(k) record lists Magstim Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HORIZON TMS Therapy System with Navigation?

The FDA product code for HORIZON TMS Therapy System with Navigation is OBP.

列明Magstim Company, 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。

K223154Magstim Horizon 3.0 TMS治疗系统，Horizon 3.0系统，Horizon 3.0，H3.0，Horizon 3.0 with StimGuide+K222171Magstim Horizon 3.0 TMS治疗系统，Horizon 3.0系统，Horizon 3.0，H3.0，Horizon 3.0 with StimGuide+K211389Magstim Horizon 3.0 TMS治疗系统，Horizon 3.0系统，Horizon 3.0，Horizon 3.0 with Navigation K203684Neurosign V4术中神经监护仪 K182853HORIZON TMS 疗法系统 K181559Neurosign V4术中神经监护仪

查看所有 10 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。