Cleared Traditional

REMI-AI Rapid Detection Module (REMI-AI RDM)

K240408 · Epitel, Inc. · Neurology

Oct 2024

Decision

251d

Days

Class 2

Risk

About This 510(k) Submission

K240408 is an FDA 510(k) clearance for the REMI-AI Rapid Detection Module (REMI-AI RDM), 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 October 17, 2024, 251 days after receiving the submission on February 9, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K240408 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 09, 2024
Decision Date	October 17, 2024
Days to Decision	251 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