Cleared Traditional

iCEWav Neuromonitoring Platform

K191868 · Ice Neurosystems, Inc. · Neurology

Mar 2020

Decision

263d

Days

Class 2

Risk

About This 510(k) Submission

K191868 is an FDA 510(k) clearance for the iCEWav Neuromonitoring Platform, a Full-montage Standard Electroencephalograph (Class II — Special Controls, product code GWQ), submitted by Ice Neurosystems, Inc. (Washington, US). The FDA issued a Cleared decision on March 31, 2020, 263 days after receiving the submission on July 12, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K191868 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 12, 2019
Decision Date	March 31, 2020
Days to Decision	263 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	GWQ — Full-montage Standard Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations