FDA 510(k)

StimRouter 神经调节系统

K号: K200482 · 2020-03-27

决定日期2020-03-27

产品代码GZF

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决定实质等同

器械摘要

StimRouter Neuromodulation System is the device name listed in this FDA 510(k) record. The listed applicant is Bioness, Inc.. It received FDA 510(k) clearance on 2020-03-27 under 510(k) number K200482. The device is classified under product code GZF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the StimRouter Neuromodulation System?

StimRouter Neuromodulation System is a medical device that received FDA 510(k) clearance on 2020-03-27. The listed applicant is Bioness, Inc.. The 510(k) number is K200482.

When did StimRouter Neuromodulation System receive FDA 510(k) clearance?

StimRouter Neuromodulation System received FDA 510(k) clearance on 2020-03-27, under 510(k) number K200482.

Who is the listed applicant for StimRouter Neuromodulation System?

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

What is the FDA product code for StimRouter Neuromodulation System?

The FDA product code for StimRouter Neuromodulation System is GZF.

列明Bioness, Inc.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。

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官方来源

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