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Panels › Neurology › Product code GWQ · Class 2

Full-Montage Standard Electroencephalograph

Regulation 882.1400

2510(k)s in 12 months (189 all time)
1recalls in 12 months (23 all time)
19recalls that name a 510(k)
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Top companies in GWQ

Company510(k)sRecalls
Nihon Kohden America, Inc.151
Excel Tech. , Ltd.150
Bio-Logic Systems Corp.52
Del Mar Avionics70
Oxford Medilog, Inc.60
Compumedics Limited32
Physiometrix, Inc.50
Teca, Inc.50
Axon Systems, Inc.40
Bioserenity40
Decided510(k)Device and applicantCode
Jun 13, 2026K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)
Neuroelectrics Barcelona S.L.U., ES
GWQ
Mar 13, 2026K260455New Wave System
Zeto, Inc.
GWQ
Apr 30, 2024K233403Flexset System
Zeto, Inc.
GWQ
Nov 9, 2023K231366Neuronaute Plus
Bioserenity Sas, FR
GWQ
Aug 31, 2023K221959Q21
Neurofield, Inc.
GWQ
Aug 18, 2023K231457SPARK Scan
Spark Neuro, Inc.
GWQ
Apr 27, 2023K221963Cumulus Functional Neurophysiology Platform
Cumulus Neuroscience Limited, IE
GWQ
Feb 9, 2023K230073Okti
Compumedics Limited, AU
GWQ
Jan 12, 2023K223644Neuronaute with IceCap 2 & IceCap 2 Small
Bioserenity, FR
GWQ
Aug 10, 2022K220056iSyncWave
iMediSync, Inc., KR
GWQ
Jun 16, 2022K212788Seer Home
Seer Medical Pty, Ltd., AU
GWQ
May 6, 2022K213900WAVi SCAN EEG System and Accessories
Wavi Co.
GWQ
Dec 30, 2020K193159NeuroAmp II, NeuroAmp II.5s
Corscience GmbH & Co. KG, DE
GWQ
Dec 10, 2020K202334Neuronaute
Bioserenity Sas, FR
GWQ
Sep 29, 2020K201819Cadwell Apollo System
Cadwell Industries, Inc.
GWQ
Apr 24, 2020K191492Maxxi Position Sensor
Neurovirtual USA, Inc.
GWQ
Mar 31, 2020K191868iCEWav Neuromonitoring Platform
Ice Neurosystems, Inc.
GWQ
Mar 17, 2020K192753NeuralScan System
Medeia, Inc.
GWQ
Sep 1, 2018K181466Cadwell Zenith System
Cadwell Industries, Inc.
GWQ
Jul 17, 2018K180269Cadwell Apollo System
Cadwell Industries, Inc.
GWQ
Jun 14, 2018K180290Natus Brain Monitor Amplifier
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA
GWQ
May 4, 2018K172271Trackit T4 EEG Amplifier
Lifelines , Ltd., GB
GWQ
Apr 17, 2018K172735WR19 System
Zeto, Inc.
GWQ
Feb 22, 2018K180181Natus Quantum
Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek), CA
GWQ
Feb 16, 2018K173460NeuroEEG
Memory MD, Inc.
GWQ
Feb 1, 2018K171384Micromed BRAIN QUICK system
Micromed S.P.A., IT
GWQ
Dec 26, 2017K170138NEURONAUTE
Bioserenity, FR
GWQ
Dec 13, 2017K171781eVox System
Evoke Neuroscience, Inc.
GWQ
Aug 25, 2017K171124Nihon Kohden Wireless Input Unit WEE-1200
Nihon Kohden Corporation, JP
GWQ
Jun 5, 2017K170441ElectroTek
Mobilemedtek
GWQ
Jun 2, 2017K162681Enobio Wireless EEG
Neuroelectrics Barcelona S.L.U., ES
GWQ
Dec 14, 2016K163163XLTEK EMU40EX EEG Headbox
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA
GWQ
Nov 4, 2016K162595Trex_HD
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA
GWQ
Jan 26, 2016K150498Discovery 24
Brainmaster Technologies, Inc.
GWQ
Aug 13, 2015K143233Mitsar-EEG
Mitsar Co., Ltd., RU
GWQ
Apr 20, 2015K143440Natus Quantum
Natus Medical Incorporated, CA
GWQ
Feb 3, 2015K131335BWMINI EEG, BWMINIHST, BWMINI PSG
Neurovirtual USA, Inc.
GWQ
Feb 14, 2014K131266TREZ_HD
Excel-Tech Ltd. (Xltek), CA
GWQ
Jan 29, 2014K133355CADWELL FLEX EEG/PSG
Cadwell Industries, Inc.
GWQ
Nov 27, 2013K131383X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE
Advanced Brain Monitoring, Inc.
GWQ
May 2, 2013K122196CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY
Blackrock Neuromed, LLC
GWQ
Nov 9, 2012K120888PSG-1100 SLEEP DIAGNOSTIC SYSTEM
Nihon Kohden Corp.
GWQ
Jun 19, 2012K112817MICROEEG SYSTEM
Bio-Signal Group Corporation
GWQ
Mar 22, 2012K113117NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX
Nihon Kohden America, Inc.
GWQ
Feb 17, 2012K112353GEODESIC EEG MOBILE 100 (GEM 100)
Electrical Geodesics, Inc.
GWQ
Oct 28, 2011K112107BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS
Neurovirtual USA, Inc.
GWQ
Aug 29, 2011K083577HARMONIE SYSTEM
Stellate Systems, CA
GWQ
Jul 29, 2011K110376PE-210AK SWITCH BOX
Nihon Kohden Corp.
GWQ
Jul 19, 2011K103129ENTROPY EASYFIT SENSOR
GE Healthcare
GWQ
Jul 30, 2010K101386VIGILANT EEG MONITOR MODEL VIGILANT 2.0
Infinite Biomedical Technologies, LLC
GWQ

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