Cleared Traditional

NicoletOne

K173366 · Natus Neurology Incorporated · Neurology
Jul 2018
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K173366 is an FDA 510(k) clearance for the NicoletOne, a Automatic Event Detection Software For Polysomnograph With Electroencephalograph (Class II — Special Controls, product code OLZ), submitted by Natus Neurology Incorporated (Middleton, US). The FDA issued a Cleared decision on July 20, 2018, 267 days after receiving the submission on October 26, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K173366 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2017
Decision Date July 20, 2018
Days to Decision 267 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code OLZ — Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1400
Definition Automatically Mark Electroencephalograph And Polysomongraph Signals In Order To Aid In Identification Of Such Events And Annotation Of Prolonged Psg Traces; Automatically Calculate Simple Measures Obtained From Recorded Signals (e.g. Magnitude, Time, Frequency And Simple Statistical Measures Of Marked Events); All Output Subject To Verification By Qualified User