Cleared Traditional

REMI Remote EEG Monitoring System

K243185 · Epitel · Neurology

Mar 2025

Decision

172d

Days

Class 2

Risk

About This 510(k) Submission

K243185 is an FDA 510(k) clearance for the REMI Remote EEG Monitoring System, a Reduced- Montage Standard Electroencephalograph (Class II — Special Controls, product code OMC), submitted by Epitel (Salt Lake City, US). The FDA issued a Cleared decision on March 21, 2025, 172 days after receiving the submission on September 30, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K243185 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2024
Decision Date	March 21, 2025
Days to Decision	172 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OMC — Reduced- Montage Standard Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A User-specified And/or Sponsor-specified Locations With A Reduced Array (i.e. Less Than < 16) Of Electrodes