Cleared Traditional

NeuroSENSE Monitoring System, Model NS-901

K202621 · Neurowave Systems, Inc. · Anesthesiology

Aug 2021

Decision

329d

Days

Class 2

Risk

About This 510(k) Submission

K202621 is an FDA 510(k) clearance for the NeuroSENSE Monitoring System, Model NS-901, a Index-generating Electroencephalograph Software (Class II — Special Controls, product code OLW), submitted by Neurowave Systems, Inc. (Cleveland Heights, US). The FDA issued a Cleared decision on August 5, 2021, 329 days after receiving the submission on September 10, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K202621 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 2020
Decision Date	August 05, 2021
Days to Decision	329 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	OLW — Index-generating Electroencephalograph Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Analyze Electrical Activity Of The Brain By Transformation Of Electroencephalograph Signals Into A Dimensionless Index Number For Use And Interpretation By A Qualified User.