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FDA 510(k)

iCEWav Neuromonitoring Platform

K-Number: K191868 · 2020-03-31

ApplicantIce Neurosystems, Inc.
Decision Date2020-03-31
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the iCEWav Neuromonitoring Platform?

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

When was iCEWav Neuromonitoring Platform approved by the FDA?

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

What company makes iCEWav Neuromonitoring Platform?

iCEWav Neuromonitoring Platform is manufactured by Ice Neurosystems, Inc..

What is the FDA product code for iCEWav Neuromonitoring Platform?

The FDA product code for iCEWav Neuromonitoring Platform is GWQ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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