Cleared Traditional

Natus NeuroWorks

K200878 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Neurology

May 2020

Decision

46d

Days

Class 2

Risk

About This 510(k) Submission

K200878 is an FDA 510(k) clearance for the Natus NeuroWorks, a Automatic Event Detection Software For Full-montage Electroencephalograph (Class II — Special Controls, product code OMB), submitted by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (Oakville, CA). The FDA issued a Cleared decision on May 18, 2020, 46 days after receiving the submission on April 2, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K200878 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 02, 2020
Decision Date	May 18, 2020
Days to Decision	46 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OMB — Automatic Event Detection Software For Full-montage Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Automatically Mark Or Identify Electroencephalograph Waveforms For Spikes, Electrographic Seizures, Seizure-like Events In Order To Aid In Identification Of Such Events And Help Review And Annotation Of Prolonged Eeg Traces; All Output Subject To Verification By Qualified User