FDA 510(k) Applications for Medical Device Product Code: OMC (Reduced- Montage Standard Electroencephalograph)

FDA 510(k) Applications for Medical Device Product Code "OMC"
(Reduced- Montage Standard Electroencephalograph)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K130013	ADVANCED BRAIN MONITORING INC.	X4 SYSTEM	01/31/2013
K120447	ADVANCED BRAIN MONITORING, INC.	X4	06/20/2012
K152040	ADVANCED BRAIN MONITORING, INC.	X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)	10/30/2015
K192549	Byteflies NV	Byteflies Kit	06/22/2020
K170363	Ceribell, Inc.	Ceribell Pocket EEG Device	05/08/2017
K013863	CLEVELAND MEDICAL DEVICES, INC.	CRYSTAL MONITOR MODEL 16	02/19/2002
K970672	CLEVELAND MEDICAL DEVICES, INC.	CRYSTAL-EEG MODEL 10 (MODEL 10)	05/22/1997
K001110	CLEVELAND MEDICAL DEVICES, INC.	CRYSTAL-EEG MODEL 15	07/05/2000
K060523	CYBERKINETICS, INC.	NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM	03/28/2006
K203827	Epitel, Inc.	REMI	03/29/2021
K230933	Epitel, Inc.	REMI Remote EEG Monitoring System	06/30/2023
K131944	JORDAN NEUROSCIENCE, INC.	IEEG	04/10/2014
K024245	MENNEN MEDICAL LTD.	ENVOY PATIENT MONITOR	05/10/2004
K223628	Neba Health, LLC	NEBA« Compact EEG2R Mobile Headset	03/02/2023
K110967	NEURALYNX INC	ENTERPRISE ELECTROPHYSIOLOGY SYSTEM	06/30/2011
K221563	Neurosteer Inc.	Neurosteer EEG Recorder	10/24/2022
K092477	NEUROWAVE SYSTEMS, INC.	NEUROSENSE MONITORING SYSTEM, MODEL NS-701	10/29/2010
K183529	Nihon Kohden Corporation	AE-120A EEG Head Set	03/19/2019
K020335	OLYMPIC MEDICAL CORP.	OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330	06/18/2002
K021485	OXFORD BIOSIGNALS LIMITED	BIOSOMNIA	09/11/2002
K042309	OXFORD BIOSIGNALS LIMITED	BIOSOMNIA-V3	09/08/2004