Cleared Traditional

REMI AI Discrete Detection Module

K231779 · Epitel, Inc. · Neurology

Jan 2024

Decision

201d

Days

Class 2

Risk

About This 510(k) Submission

K231779 is an FDA 510(k) clearance for the REMI AI Discrete Detection Module, a Automatic Event Detection Software For Full-montage Electroencephalograph (Class II — Special Controls, product code OMB), submitted by Epitel, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 3, 2024, 201 days after receiving the submission on June 16, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K231779 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 2023
Decision Date	January 03, 2024
Days to Decision	201 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