Cleared Traditional

REMI Remote EEG Monitoring System

K230933 · Epitel, Inc. · Neurology

Jun 2023

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K230933 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, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on June 30, 2023, 88 days after receiving the submission on April 3, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K230933 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 03, 2023
Decision Date	June 30, 2023
Days to Decision	88 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