Cleared Traditional

NeuroMatch

K241390 · LVIS Corporation · Neurology

Nov 2024

Decision

195d

Days

Class 2

Risk

About This 510(k) Submission

K241390 is an FDA 510(k) clearance for the NeuroMatch, a Automatic Event Detection Software For Full-montage Electroencephalograph (Class II — Special Controls, product code OMB), submitted by LVIS Corporation (Palo Alto, US). The FDA issued a Cleared decision on November 26, 2024, 195 days after receiving the submission on May 15, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K241390 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 2024
Decision Date	November 26, 2024
Days to Decision	195 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