Full-Montage Standard Electroencephalograph

FDA product code GWQ · 184 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.1400
Review panel: NE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-02-14 – 2026-06-13

Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

GWQ 2026-06-13

Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)

Applicant Neuroelectrics Barcelona S.L.U.

K number K261604

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GWQ 2026-03-13

New Wave System

Applicant Zeto, Inc.

K number K260455

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GWQ 2024-04-30

Flexset System

Applicant Zeto, Inc.

K number K233403

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GWQ 2023-11-09

Neuronaute Plus

Applicant Bioserenity Sas

K number K231366

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GWQ 2023-08-31

Q21

Applicant Neurofield, Inc.

K number K221959

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GWQ 2023-08-18

SPARK Scan

Applicant Spark Neuro, Inc.

K number K231457

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GWQ 2023-04-27

Cumulus Functional Neurophysiology Platform

Applicant Cumulus Neuroscience Limited

K number K221963

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GWQ 2023-02-09

Okti

Applicant Compumedics Limited

K number K230073

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GWQ 2023-01-12

Neuronaute with IceCap 2 & IceCap 2 Small

Applicant Bioserenity

K number K223644

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GWQ 2022-08-10

iSyncWave

Applicant iMediSync, Inc.

K number K220056

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GWQ 2022-06-16

Seer Home

Applicant Seer Medical Pty, Ltd.

K number K212788

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GWQ 2022-05-06

WAVi SCAN EEG System and Accessories

Applicant Wavi Co.

K number K213900

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GWQ 2020-12-30

NeuroAmp II, NeuroAmp II.5s

Applicant Corscience GmbH & Co. KG

K number K193159

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GWQ 2020-12-10

Neuronaute

Applicant Bioserenity Sas

K number K202334

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GWQ 2020-09-29

Cadwell Apollo System

Applicant Cadwell Industries, Inc.

K number K201819

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GWQ 2020-04-24

Maxxi Position Sensor

Applicant Neurovirtual USA, Inc.

K number K191492

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GWQ 2020-03-31

iCEWav Neuromonitoring Platform

Applicant Ice Neurosystems, Inc.

K number K191868

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GWQ 2020-03-17

NeuralScan System

Applicant Medeia, Inc.

K number K192753

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GWQ 2018-09-01

Cadwell Zenith System

Applicant Cadwell Industries, Inc.

K number K181466

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GWQ 2018-07-17

Cadwell Apollo System

Applicant Cadwell Industries, Inc.

K number K180269

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GWQ 2018-06-14

Natus Brain Monitor Amplifier

Applicant Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

K number K180290

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GWQ 2018-05-04

Trackit T4 EEG Amplifier

Applicant Lifelines , Ltd.

K number K172271

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GWQ 2018-04-17

WR19 System

Applicant Zeto, Inc.

K number K172735

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GWQ 2018-02-22

Natus Quantum

Applicant Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek)

K number K180181

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GWQ 2018-02-16

NeuroEEG

Applicant Memory MD, Inc.

K number K173460

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GWQ 2018-02-01

Micromed BRAIN QUICK system

Applicant Micromed S.P.A.

K number K171384

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GWQ 2017-12-26

NEURONAUTE

Applicant Bioserenity

K number K170138

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GWQ 2017-12-13

eVox System

Applicant Evoke Neuroscience, Inc.

K number K171781

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GWQ 2017-08-25

Nihon Kohden Wireless Input Unit WEE-1200

Applicant Nihon Kohden Corporation

K number K171124

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GWQ 2017-06-05

ElectroTek

Applicant Mobilemedtek

K number K170441

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GWQ 2017-06-02

Enobio Wireless EEG

Applicant Neuroelectrics Barcelona S.L.U.

K number K162681

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GWQ 2016-12-14

XLTEK EMU40EX EEG Headbox

Applicant Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

K number K163163

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GWQ 2016-11-04

Trex_HD

Applicant Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

K number K162595

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GWQ 2016-01-26

Discovery 24

Applicant Brainmaster Technologies, Inc.

K number K150498

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GWQ 2013-11-27

X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE

Applicant Advanced Brain Monitoring, Inc.

K number K131383

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GWQ 2013-05-02

CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY

Applicant Blackrock Neuromed, LLC

K number K122196

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GWQ 2012-11-09

PSG-1100 SLEEP DIAGNOSTIC SYSTEM

Applicant Nihon Kohden Corp.

K number K120888

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GWQ 2012-06-19

MICROEEG SYSTEM

Applicant Bio-Signal Group Corporation

K number K112817

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GWQ 2012-03-22

NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX

Applicant Nihon Kohden America, Inc.

K number K113117

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GWQ 2012-02-17

GEODESIC EEG MOBILE 100 (GEM 100)

Applicant Electrical Geodesics, Inc.

K number K112353

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GWQ 2011-10-28

BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS

Applicant Neurovirtual USA, Inc.

K number K112107

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GWQ 2011-08-29

HARMONIE SYSTEM

Applicant Stellate Systems

K number K083577

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GWQ 2011-07-29

PE-210AK SWITCH BOX

Applicant Nihon Kohden Corp.

K number K110376

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GWQ 2011-07-19

ENTROPY EASYFIT SENSOR

Applicant GE Healthcare

K number K103129

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GWQ 2010-07-30

VIGILANT EEG MONITOR MODEL VIGILANT 2.0

Applicant Infinite Biomedical Technologies, LLC

K number K101386

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GWQ 2010-04-09

NEUROLINK IP MODEL: PK1117

Applicant Natus Medical Incorporated

K number K100683

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GWQ 2010-01-15

COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG

Applicant Compumedics Limited

K number K093223

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GWQ 2008-10-31

NEUROLINK IP, MODEL PK1113

Applicant Excel-Tech Ltd. (Xltek)

K number K081741

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GWQ 2008-09-08

COMPUMEDICS NEUVO

Applicant Compumedics USA, Ltd.

K number K081151

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GWQ 2007-06-07

SACS EEG WORKSTATION A7

Applicant Sacs Medical AB

K number K071109

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GWQ 2006-11-06

NICOLETONE SYSTEM V32 AMPLIFIER

Applicant Viasys Neuro Care

K number K061908

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GWQ 2006-04-21

XLTEK EMU40 EEG HEADBOX, MODEL PK1072

Applicant Excel Tech. , Ltd.

K number K053386

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GWQ 2005-09-12

COGNITRACE

Applicant Eemagine Medical Imaging Solutions GmbH

K number K051825

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GWQ 2005-03-28

NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM

Applicant Cyberkinetics, Inc.

K number K042626

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GWQ 2005-01-26

GEODESIC PHOTOGRAMMETRY SYSTEM

Applicant Electrical Geodesics, Incorporated

K number K043309

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GWQ 2004-08-27

XLTEK TREX MODEL#10309

Applicant Excel Tech. , Ltd.

K number K042150

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GWQ 2004-08-04

GEODESIC EEG SYSTEM SERIES 100

Applicant Electrical Geodesics, Incorporated

K number K033399

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GWQ 2004-07-16

ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256

Applicant Manufacturing Technology, Inc.

K number K040554

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GWQ 2004-03-12

EMU128S, MODEL EX-NW-128S

Applicant Excel Tech. , Ltd.

K number K040360

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GWQ 2004-02-18

ADAM

Applicant Astro-Med, Inc.

K number K033978

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GWQ 2003-02-06

SYNAMPS2

Applicant Neuroscan

K number K023771

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GWQ 2002-10-09

EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION

Applicant Axon Systems, Inc.

K number K022785

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GWQ 2002-08-13

96 CHANNEL EEG HEADBOX MODEL EMU96

Applicant Excel Tech. , Ltd.

K number K021599

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GWQ 2002-01-14

80 CHANNEL EEG

Applicant Xltek

K number K014147

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GWQ 2002-01-14

84 CHANNEL EEG

Applicant Xltek

K number K014146

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GWQ 2001-10-15

PAM-RL

Applicant Individual Monitoring Systems, Inc.

K number K010997

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GWQ 2001-09-19

GEODESIC EEG SYSTEM, MODEL 200

Applicant Electrical Geodesics, Incorporated

K number K012079

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GWQ 2001-06-06

UNIQUE AMBULATORY EEG

Applicant Axon Systems, Inc.

K number K010697

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GWQ 2001-06-04

NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1

Applicant Thuris Corp.

K number K010669

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GWQ 2001-05-31

ACTIWARE-PLMS

Applicant Mini-Mitter Co., Inc.

K number K011430

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GWQ 2001-04-09

REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)

Applicant Excel Tech. , Ltd.

K number K010086

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GWQ 2001-03-26

REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED)

Applicant Excel Tech. , Ltd.

K number K010089

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GWQ 2001-03-26

REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED)

Applicant Excel Tech. , Ltd.

K number K010088

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GWQ 2001-03-16

REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP

Applicant Excel Tech. , Ltd.

K number K010084

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GWQ 2001-02-09

64 CHANNEL EEG / MODEL NUMBER EX-NW-64

Applicant Excel Tech. , Ltd.

K number K010150

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GWQ 2001-02-01

EEG WITH VIDEO, MODEL EX-NW

Applicant Excel Tech. , Ltd.

K number K010091

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GWQ 2000-10-26

PHOENIX DIGITAL EEG

Applicant Axon Systems, Inc.

K number K002316

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GWQ 2000-09-14

BIO-LOGIC CEEGRAPH NETLINK

Applicant Bio-Logic Systems Corp.

K number K002570

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GWQ 2000-08-31

128 CHANNEL EEG HEADBOX, MODEL EX-NW-128

Applicant Excel Tech. , Ltd.

K number K000919

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GWQ 2000-06-30

WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)

Applicant Excel Tech. , Ltd.

K number K001103

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GWQ 2000-04-14

EEG WITH VIDEO, MODEL EX-NW

Applicant Excel Tech. , Ltd.

K number K000898

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GWQ 1999-11-03

BRAVO MULTI-MODALITY SYSTEM

Applicant Nicolet Biomedical, Inc.

K number K991054

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GWQ 1999-10-15

ACTITRAC

Applicant Individual Monitoring Systems, Inc.

K number K992410

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GWQ 1999-06-23

ACTIWATCH-SCORE

Applicant Mini-Mitter Co., Inc.

K number K991033

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GWQ 1999-03-23

ACTIWATCH

Applicant Mini-Mitter Co., Inc.

K number K983533

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GWQ 1998-10-14

EXCEL AMBULATORY EEG

Applicant Excel Tech. , Ltd.

K number K982479

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GWQ 1998-04-21

EXCEL NEURO WORKS

Applicant Excel Tech. , Ltd.

K number K980214

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GWQ 1998-03-05

BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM

Applicant Bio-Logic Systems Corp.

K number K973883

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GWQ 1998-02-26

NEUROAMP EEG AMPLIFIER

Applicant Neurocorp, Ltd.

K number K974495

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GWQ 1997-11-20

CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM)

Applicant Ctf Systems, Inc.

K number K971329

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GWQ 1997-07-23

DEEG-LITE

Applicant Grass-Telefactor Product Group

K number K972202

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GWQ 1997-06-25

SATELLITE

Applicant Nicolet Biomedical, Inc.

K number K971331

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GWQ 1997-06-02

MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM

Applicant Physiometrix, Inc.

K number K970942

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GWQ 1997-05-19

GALILEO HALLEY

Applicant Biosound Esaote, Inc.

K number K970703

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GWQ 1997-01-27

DG NERVUS

Applicant Medelec , Ltd.

K number K964280

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GWQ 1997-01-17

MEDILOG MR95

Applicant Oxford Instruments, Plc.

K number K961642

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GWQ 1996-12-12

EQUINOX DIGITAL EEG SYSTEM

Applicant Physiometrix, Inc.

K number K962447

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GWQ 1996-11-25

MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM

Applicant Physiometrix, Inc.

K number K962157

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GWQ 1996-01-25

CEEGRAPH TRAVELER AMBULATORY EEG RECORDER

Applicant Bio-Logic Systems Corp.

K number K954954

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GWQ 1995-10-12

MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS

Applicant Physiometrix, Inc.

K number K953449

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