FDA 510(k)

iCEWav 神经监护平台

K号: K191868 · 2020-03-31

决定日期2020-03-31

产品代码GWQ

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决定实质等同

器械摘要

iCEWav Neuromonitoring Platform is the device name listed in this FDA 510(k) record. The listed applicant is Ice Neurosystems, Inc.. It received FDA 510(k) clearance on 2020-03-31 under 510(k) number K191868. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the iCEWav Neuromonitoring Platform?

iCEWav Neuromonitoring Platform is a medical device that received FDA 510(k) clearance on 2020-03-31. The listed applicant is Ice Neurosystems, Inc.. The 510(k) number is K191868.

When did iCEWav Neuromonitoring Platform receive FDA 510(k) clearance?

iCEWav Neuromonitoring Platform received FDA 510(k) clearance on 2020-03-31, under 510(k) number K191868.

Who is the listed applicant for iCEWav Neuromonitoring Platform?

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

What is the FDA product code for iCEWav Neuromonitoring Platform?

The FDA product code for iCEWav Neuromonitoring Platform is GWQ.

列明Ice Neurosystems, 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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