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 |
| K231366 | BioSerenity SAS | Neuronaute Plus | 11/09/2023 |
| 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 |
| K233403 | Zeto, Inc. | Flexset System | 04/30/2024 |
| K172735 | Zeto, Inc. | WR19 System | 04/17/2018 |
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