REMI Remote EEG Monitoring System

Q: When was REMI Remote EEG Monitoring System cleared by the FDA?

REMI Remote EEG Monitoring System (K230933) received a 510(k) decision of Substantially Equivalent on June 30, 2023, 88 days after the submission was received.

Q: What is the product code of K230933?

The FDA product code is OMC – Reduced- Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.

FDA 510(k) K230933 · Epitel, Inc.

Substantially Equivalent

510(k) numberK230933

Submission

Device name: REMI Remote EEG Monitoring System
Applicant: Epitel, Inc.
Salt Lake City, UT, US
Received: April 3, 2023
Decision date: June 30, 2023
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OMC – Reduced- Montage Standard Electroencephalograph
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.1400
Specialty: Neurology

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

Other 510(k)s with product code OMC

510(k)	Device	Applicant	Decision
K261101	Ceribell MonitorOMC · Traditional	Ceribell, Inc.	06/30/2026SE
K251550	NX01 (NX01)OMC · Traditional	Naox Technologies Sas	11/25/2025SE
K251726	SignalNED System (Model RE)OMC · Traditional	Forest Devices, Inc.	09/03/2025SE
K243185	REMI Remote EEG Monitoring SystemOMC · Traditional	Epitel	03/21/2025SE
K242930	Natus BrainWatch SystemOMC · Traditional	Natus Medical Incorporated Dba Excel-Tech Ltd.…	11/19/2024SE
K232779	Quex Ed; Quex SOMC · Traditional	Qx World, Ltd.	10/11/2024SE
K242306	SignalNED System (Model RE)OMC · Traditional	Forest Devices, Inc.	09/04/2024SE
K223628	NEBA® Compact EEG2R Mobile HeadsetOMC · Traditional	Neba Health, LLC	03/02/2023SE
K221563	Neurosteer EEG RecorderOMC · Traditional	Neurosteer, Inc.	10/24/2022SE
K203827	RemiOMC · Traditional	Epitel, Inc.	03/29/2021SE

More from Epitel, Inc.

510(k)	Device	Decision
K243185	REMI Remote EEG Monitoring SystemOMC · Traditional	03/21/2025SE
K240408	REMI-AI Rapid Detection Module (REMI-AI RDM)OMB · Traditional	10/17/2024SE
K231779	REMI AI Discrete Detection ModuleOMB · Traditional	01/03/2024SE
K203827	RemiOMC · Traditional	03/29/2021SE

Questions and answers

When was REMI Remote EEG Monitoring System cleared by the FDA?

REMI Remote EEG Monitoring System (K230933) received a 510(k) decision of Substantially Equivalent on June 30, 2023, 88 days after the submission was received.

What is the product code of K230933?

The FDA product code is OMC – Reduced- Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.