FDA 510(k)

Neurosign V4术中神经监护仪

K号: K203684 · 2021-03-17

决定日期2021-03-17

产品代码PDQ

咨询委员会医疗设备监管文本描述翻译如下：关于[公司/产品名称]的监管信息： - 美国食品药品监督管理局（FDA）批准号：[510(k)编号] - 预市场批准（PMA）申请号：[PMA编号] - 临床试验注册号（NCT）：[NCT编号] - 医学文献标识符（PMID）：[PMID编号] - 产品标识符：[标识符] - 相关政策：医疗监管政策v1 - 更多信息请访问：[URL] 请注意，以上翻译保留了公司/产品名称、FDA、510(k)、PMA、NCT、PMID、标识符和URL。

决定实质等同

器械摘要

Neurosign V4 Intraoperative Nerve Monitor 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 2021-03-17 under 510(k) number K203684. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Neurosign V4 Intraoperative Nerve Monitor?

Neurosign V4 Intraoperative Nerve Monitor is a medical device that received FDA 510(k) clearance on 2021-03-17. The listed applicant is Magstim Company, Ltd.. The 510(k) number is K203684.

When did Neurosign V4 Intraoperative Nerve Monitor receive FDA 510(k) clearance?

Neurosign V4 Intraoperative Nerve Monitor received FDA 510(k) clearance on 2021-03-17, under 510(k) number K203684.

Who is the listed applicant for Neurosign V4 Intraoperative Nerve Monitor?

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 Neurosign V4 Intraoperative Nerve Monitor?

The FDA product code for Neurosign V4 Intraoperative Nerve Monitor is PDQ.

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 K183376HORIZON TMS 疗法系统带导航 K182853HORIZON TMS 疗法系统 K181559Neurosign V4术中神经监护仪

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官方来源

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