Product Code: OMC FDA class 2 21 CFR 882.1400

Reduced- Montage Standard Electroencephalograph

Neurology

The Reduced-Montage Standard Electroencephalograph (product code OMC) is a Class 2 neurological device regulated under 21 CFR 882.1400 in the Neurology specialty (NE), cleared via 510(k). It acquires, displays, stores, and archives electroencephalographic signals from the brain using a user-specified or sponsor-specified reduced electrode array of fewer than 16 electrodes, as distinct from full-montage EEG systems. The device is eligible for third-party review and is not an implant or life-sustaining device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: OMC
Device Class: FDA class 2
Regulation Number: 882.1400
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

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

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 28 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251550	NX01 (NX01)	Nov 25, 2025	Substantially Equivalent	Naox Technologies Sas
K251726	SignalNED System (Model RE)	Sep 03, 2025	Substantially Equivalent	Forest Devices, Inc.
K243185	REMI Remote EEG Monitoring System	Mar 21, 2025	Substantially Equivalent	Epitel
K242930	Natus BrainWatch System	Nov 19, 2024	Substantially Equivalent	Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
K232779	QUEX ED; QUEX S	Oct 11, 2024	Substantially Equivalent	Qx World, Ltd.
K242306	SignalNED System (Model RE)	Sep 04, 2024	Substantially Equivalent	Forest Devices, Inc.
K230933	REMI Remote EEG Monitoring System	Jun 30, 2023	Substantially Equivalent	Epitel, Inc.
K223628	NEBA® Compact EEG2R Mobile Headset	Mar 02, 2023	Substantially Equivalent	Neba Health, LLC
K221563	Neurosteer EEG Recorder	Oct 24, 2022	Substantially Equivalent	Neurosteer, Inc.
K203827	REMI	Mar 29, 2021	Substantially Equivalent	Epitel, Inc.
K192549	Byteflies Kit	Jun 22, 2020	Substantially Equivalent	Byteflies NV
K183529	AE-120A EEG Head Set	Mar 19, 2019	Substantially Equivalent	Nihon Kohden Corporation
K170363	Ceribell Pocket EEG Device	May 08, 2017	Substantially Equivalent	Ceribell, Inc.
K152040	X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)	Oct 30, 2015	Substantially Equivalent	Advanced Brain Monitoring, Inc.
K131944	IEEG	Apr 10, 2014	Substantially Equivalent	Jordan Neuroscience, Inc.
K130013	X4 SYSTEM	Jan 31, 2013	Substantially Equivalent	Advanced Brain Monitoring, Inc.
K120447	X4	Jun 20, 2012	Substantially Equivalent	Advanced Brain Monitoring, Inc.
K110967	ENTERPRISE ELECTROPHYSIOLOGY SYSTEM	Jun 30, 2011	Substantially Equivalent	Neuralynx, Inc.
K092477	NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701	Oct 29, 2010	Substantially Equivalent	Neurowave Systems, Inc.
K060523	NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM	Mar 28, 2006	Substantially Equivalent	Cyberkinetics, Inc.
K042309	BIOSOMNIA-V3	Sep 08, 2004	Substantially Equivalent	Oxford Biosignals Limited
K024245	ENVOY PATIENT MONITOR	May 10, 2004	Substantially Equivalent	Mennen Medical , Ltd.
K021485	BIOSOMNIA	Sep 11, 2002	Substantially Equivalent	Oxford Biosignals Limited
K020335	OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330	Jun 18, 2002	Substantially Equivalent	Olympic Medical Corp.
K013863	CRYSTAL MONITOR MODEL 16	Feb 19, 2002	Substantially Equivalent	Cleveland Medical Devices, Inc.
K001110	CRYSTAL-EEG MODEL 15	Jul 05, 2000	Substantially Equivalent	Cleveland Medical Devices, Inc.
K970672	CRYSTAL-EEG MODEL 10 (MODEL 10)	May 22, 1997	Substantially Equivalent	Cleveland Medical Devices, Inc.
K781130	ACCESSORY TO ECG ANALYSIS SYS.	Aug 23, 1978	Substantially Equivalent	Oxford Medilog, Inc.