Cleared Traditional

LVIS NeuroMatch

K222450 · LVIS Corporation · Neurology

Jun 2023

Decision

298d

Days

Class 2

Risk

About This 510(k) Submission

K222450 is an FDA 510(k) clearance for the LVIS 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 June 9, 2023, 298 days after receiving the submission on August 15, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K222450 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 15, 2022
Decision Date	June 09, 2023
Days to Decision	298 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