FDA 510(k) Applications for Medical Device Product Code "GWQ"
(Electroencephalograph)

FDA 510(k) Number Applicant Device Name Decision Date
K131383 ADVANCED BRAIN MONITORING INC. X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE 11/27/2013
K033978 ASTRO-MED, INC. ADAM 02/18/2004
K022785 AXON SYSTEMS, INC. EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION 10/09/2002
K002316 AXON SYSTEMS, INC. PHOENIX DIGITAL EEG 10/26/2000
K010697 AXON SYSTEMS, INC. UNIQUE AMBULATORY EEG 06/06/2001
K973883 BIO-LOGIC SYSTEMS CORP. BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM 03/05/1998
K002570 BIO-LOGIC SYSTEMS CORP. BIO-LOGIC CEEGRAPH NETLINK 09/14/2000
K954954 BIO-LOGIC SYSTEMS CORP. CEEGRAPH TRAVELER AMBULATORY EEG RECORDER 01/25/1996
K112817 BIO-SIGNAL GROUP CORPORATION MICROEEG SYSTEM 06/19/2012
K170138 BIOSERENITY NEURONAUTE 12/26/2017
K223644 Bioserenity Neuronaute with IceCap 2 & IceCap 2 Small 01/12/2023
K202334 Bioserenity SAS Neuronaute 12/10/2020
K970703 BIOSOUND ESAOTE, INC. GALILEO HALLEY 05/19/1997
K122196 BLACKROCK NEUROMED, LLC CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY 05/02/2013
K150498 BRAINMASTER TECHNOLOGIES, INC. Discovery 24 01/26/2016
K180269 Cadwell Industries, Inc. Cadwell Apollo System 07/17/2018
K201819 Cadwell Industries, Inc. Cadwell Apollo System 09/29/2020
K133355 CADWELL INDUSTRIES, INC. CADWELL FLEX EEG/PSG 01/29/2014
K181466 Cadwell Industries, Inc. Cadwell Zenith System 09/01/2018
K093223 COMPUMEDICS LIMITED COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG 01/15/2010
K230073 Compumedics Limited Okti 02/09/2023
K081151 COMPUMEDICS USA, LTD. COMPUMEDICS NEUVO 09/08/2008
K193159 Corscience gmbH & Co. KG NeuroAmp II, NeuroAmp II.5s 12/30/2020
K971329 CTF SYSTEMS, INC. CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM) 11/20/1997
K221963 Cumulus Neuroscience Limited Cumulus Functional Neurophysiology Platform 04/27/2023
K042626 CYBERKINETICS, INC. NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM 03/28/2005
K051825 EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH COGNITRACE 09/12/2005
K112353 ELECTRICAL GEODESICS, INC. GEODESIC EEG MOBILE 100 (GEM 100) 02/17/2012
K033399 ELECTRICAL GEODESICS, INCORPORATED GEODESIC EEG SYSTEM SERIES 100 08/04/2004
K012079 ELECTRICAL GEODESICS, INCORPORATED GEODESIC EEG SYSTEM, MODEL 200 09/19/2001
K043309 ELECTRICAL GEODESICS, INCORPORATED GEODESIC PHOTOGRAMMETRY SYSTEM 01/26/2005
K171781 Evoke Neuroscience, Inc. eVox System 12/13/2017
K000919 EXCEL TECH. LTD. 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128 08/31/2000
K010150 EXCEL TECH. LTD. 64 CHANNEL EEG / MODEL NUMBER EX-NW-64 02/09/2001
K021599 EXCEL TECH. LTD. 96 CHANNEL EEG HEADBOX MODEL EMU96 08/13/2002
K000898 EXCEL TECH. LTD. EEG WITH VIDEO, MODEL EX-NW 04/14/2000
K010091 EXCEL TECH. LTD. EEG WITH VIDEO, MODEL EX-NW 02/01/2001
K040360 EXCEL TECH. LTD. EMU128S, MODEL EX-NW-128S 03/12/2004
K982479 EXCEL TECH. LTD. EXCEL AMBULATORY EEG 10/14/1998
K980214 EXCEL TECH. LTD. EXCEL NEURO WORKS 04/21/1998
K010088 EXCEL TECH. LTD. REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED) 03/26/2001
K010086 EXCEL TECH. LTD. REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED) 04/09/2001
K010084 EXCEL TECH. LTD. REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP 03/16/2001
K010089 EXCEL TECH. LTD. REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED) 03/26/2001
K001103 EXCEL TECH. LTD. WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED) 06/30/2000
K053386 EXCEL TECH. LTD. XLTEK EMU40 EEG HEADBOX, MODEL PK1072 04/21/2006
K042150 EXCEL TECH. LTD. XLTEK TREX MODEL#10309 08/27/2004
K081741 EXCEL-TECH LTD. (XLTEK) NEUROLINK IP, MODEL PK1113 10/31/2008
K131266 EXCEL-TECH LTD. (XLTEK) TREZ_HD 02/14/2014
K103129 GE HEALTHCARE ENTROPY EASYFIT SENSOR 07/19/2011
K972202 GRASS-TELEFACTOR PRODUCT GROUP DEEG-LITE 07/23/1997
K191868 iCE Neurosystems, Inc. iCEWav Neuromonitoring Platform 03/31/2020
K220056 iMediSync Inc. iSyncWave 08/10/2022
K992410 INDIVIDUAL MONITORING SYSTEMS, INC. ACTITRAC 10/15/1999
K010997 INDIVIDUAL MONITORING SYSTEMS, INC. PAM-RL 10/15/2001
K101386 INFINITE BIOMEDICAL TECHNOLOGIES, LLC VIGILANT EEG MONITOR MODEL VIGILANT 2.0 07/30/2010
K172271 Lifelines Ltd. Trackit T4 EEG Amplifier 05/04/2018
K040554 MANUFACTURING TECHNOLOGY, INC. ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256 07/16/2004
K192753 Medeia, Inc. NeuralScan System 03/17/2020
K964280 MEDELEC LTD. DG NERVUS 01/27/1997
K173460 MemoryMD Inc. NeuroEEG 02/16/2018
K171384 Micromed S.P.A Micromed BRAIN QUICK system 02/01/2018
K011430 MINI-MITTER CO., INC. ACTIWARE-PLMS 05/31/2001
K983533 MINI-MITTER CO., INC. ACTIWATCH 03/23/1999
K991033 MINI-MITTER CO., INC. ACTIWATCH-SCORE 06/23/1999
K143233 MITSAR CO., LTD Mitsar-EEG 08/13/2015
K170441 MobileMedTek ElectroTek 06/05/2017
K143440 NATUS MEDICAL INCORPORATED Natus Quantum 04/20/2015
K100683 NATUS MEDICAL INCORPORATED NEUROLINK IP MODEL: PK1117 04/09/2010
K180181 Natus Medical Incorporated DBA Excel_tech Ltd. (XLTEK) Natus Quantum 02/22/2018
K180290 Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) Natus Brain Monitor Amplifier 06/14/2018
K162595 Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Trex_HD 11/04/2016
K163163 Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) XLTEK EMU40EX EEG Headbox 12/14/2016
K974495 NEUROCORP, LTD. NEUROAMP EEG AMPLIFIER 02/26/1998
K162681 Neuroelectrics Barcelona S.L.U. Enobio Wireless EEG 06/02/2017
K221959 NeuroField Inc. Q21 08/31/2023
K023771 NEUROSCAN SYNAMPS2 02/06/2003
K112107 NEUROVIRTUAL USA, INC. BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS 10/28/2011
K131335 NEUROVIRTUAL USA, INC. BWMINI EEG, BWMINIHST, BWMINI PSG 02/03/2015
K191492 Neurovirtual USA, INC. Maxxi Position Sensor 04/24/2020
K991054 NICOLET BIOMEDICAL, INC. BRAVO MULTI-MODALITY SYSTEM 11/03/1999
K971331 NICOLET BIOMEDICAL, INC. SATELLITE 06/25/1997
K113117 NIHON KOHDEN AMERICA, INC. NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX 03/22/2012
K110376 NIHON KOHDEN CORP. PE-210AK SWITCH BOX 07/29/2011
K120888 NIHON KOHDEN CORP. PSG-1100 SLEEP DIAGNOSTIC SYSTEM 11/09/2012
K171124 Nihon Kohden Corporation Nihon Kohden Wireless Input Unit WEE-1200 08/25/2017
K961642 OXFORD INSTRUMENTS, PLC. MEDILOG MR95 01/17/1997
K962447 PHYSIOMETRIX, INC. EQUINOX DIGITAL EEG SYSTEM 12/12/1996
K962157 PHYSIOMETRIX, INC. MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM 11/25/1996
K970942 PHYSIOMETRIX, INC. MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM 06/02/1997
K071109 SACS MEDICAL AB SACS EEG WORKSTATION A7 06/07/2007
K212788 Seer Medical Pty Ltd Seer Home 06/16/2022
K231457 SPARK Neuro Inc. SPARK Scan 08/18/2023
K083577 STELLATE SYSTEMS HARMONIE SYSTEM 08/29/2011
K010669 THURIS CORP. NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1 06/04/2001
K061908 VIASYS NEUROCARE NICOLETONE SYSTEM V32 AMPLIFIER 11/06/2006
K213900 WAVi Co. WAVi SCAN EEG System and Accessories 05/06/2022
K014147 XLTEK 80 CHANNEL EEG 01/14/2002
K014146 XLTEK 84 CHANNEL EEG 01/14/2002
K172735 Zeto, Inc. WR19 System 04/17/2018


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