Cleared Traditional

NEAT 001

K250058 · Brain Electrophysiology Laboratory Company, LLC · Neurology
Apr 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K250058 is an FDA 510(k) clearance for the NEAT 001, a Automatic Event Detection Software For Polysomnograph With Electroencephalograph (Class II — Special Controls, product code OLZ), submitted by Brain Electrophysiology Laboratory Company, LLC (Eugene, US). The FDA issued a Cleared decision on April 10, 2025, 90 days after receiving the submission on January 10, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K250058 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2025
Decision Date April 10, 2025
Days to Decision 90 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