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
K842784 ADVANCED INSTRUMENTS, INC. CEREGROTRAC 01/10/1985
K894044 AMBULATORY MONITORING, INC. ACTILLUME 12/22/1989
K854030 AMBULATORY MONITORING, INC. WRIST ACTIGRAPH 06/25/1986
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
K863193 AXON SYSTEMS, INC. SENTINEL 4 EEG ANALYZER 12/02/1986
K010697 AXON SYSTEMS, INC. UNIQUE AMBULATORY EEG 06/06/2001
K781041 BECKMAN INSTRUMENTS, INC. ELECTROENCEPHALOGRAPH ACCUTRACE 100 06/28/1978
K781005 BECKMAN INSTRUMENTS, INC. ELECTROENCEPHALOGRAPH ACCUTRATE 200 06/28/1978
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
K895125 BIO-LOGIC SYSTEMS CORP. CEEGRAPH 12/22/1989
K954954 BIO-LOGIC SYSTEMS CORP. CEEGRAPH TRAVELER AMBULATORY EEG RECORDER 01/25/1996
K933233 BIO-LOGIC SYSTEMS CORP. CEEGRAPH, MODIFICATION 03/03/1994
K864928 BIO-SCAN, INC. BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER 03/31/1987
K841684 BIO-SCAN, INC. BIO/SCAN BIOLOG CASSETTE RECORDER 06/07/1984
K841683 BIO-SCAN, INC. Q.P. PREAMPLIFIER SYS 06/07/1984
K112817 BIO-SIGNAL GROUP CORPORATION MICROEEG SYSTEM 06/19/2012
K170138 BIOSERENITY NEURONAUTE 12/26/2017
K970703 BIOSOUND ESAOTE, INC. GALILEO HALLEY 05/19/1997
K923860 BIOSOUND, INC. THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR 02/04/1993
K923950 BIOSOUND, INC. THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH 01/26/1993
K923894 BIOSOUND, INC. YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH 03/10/1993
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
K133355 CADWELL INDUSTRIES, INC. CADWELL FLEX EEG/PSG 01/29/2014
K181466 Cadwell Industries, Inc. Cadwell Zenith System 09/01/2018
K872183 CADWELL LABORATORIES, INC. AMBULATORY EEG PLAYBACK 07/21/1987
K946094 CADWELL LABORATORIES, INC. CADWELL EASY AMBULATORY EEG 09/12/1995
K932407 CADWELL LABORATORIES, INC. CADWELL EASY WRITER AND EASY READER 03/22/1994
K894276 CADWELL LABORATORIES, INC. CADWELL FREEDOM EEG DEVICE 09/29/1989
K941551 CLEVELAND CLINIC FOUNDATION THE VANGUARD SYSTEM 01/13/1995
K901549 CNS, INC. CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE. 10/24/1990
K093223 COMPUMEDICS LIMITED COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG 01/15/2010
K081151 COMPUMEDICS USA, LTD. COMPUMEDICS NEUVO 09/08/2008
K971329 CTF SYSTEMS, INC. CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM) 11/20/1997
K042626 CYBERKINETICS, INC. NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM 03/28/2005
K911229 DANTEC MEDICAL, INC. PHOENIX DIGITAL EEG SYSTEM 09/30/1991
K841653 DEL MAR AVIONICS DEL MAR AVIONICS 5509 NEURO-SCANNER 12/03/1984
K854268 DEL MAR AVIONICS DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER 03/27/1986
K822700 DEL MAR AVIONICS DEL MAR MODEL 5500 EEG SCANNER 10/04/1982
K820603 DEL MAR AVIONICS OTE BIOMEDICA NEUROGRAPH 14 03/23/1982
K820605 DEL MAR AVIONICS OTE BIOMEDICA NEUROGRAPH 18 03/23/1982
K820604 DEL MAR AVIONICS OTE BIOMEDICA NEUROGRAPH 9 03/23/1982
K820779 DEL MAR AVIONICS OTE BIOMEDICAL #1296 - 16 CHAN. RECORD 04/26/1982
K883557 DURDEN ENTERPRISES, INC. NEUROWAVE SYSTEM 2 12/16/1988
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
K933951 ESAOTE BIOMEDICA SPA VIDEO EEG OPTION MODIFICATION 02/03/1994
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
K870432 GRASS-TELEFACTOR PRODUCT GROUP "A1-A2" AMBULATORY EEG CASSETTE RECORDER 05/08/1987
K972202 GRASS-TELEFACTOR PRODUCT GROUP DEEG-LITE 07/23/1997
K925838 GRASS-TELEFACTOR PRODUCT GROUP TELEFACTOR D/EEG-32 04/30/1993
K902752 IMEXCO GENERAL LTD. NEURITOR 2001 12/04/1990
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
K910972 INOMED MEDIZINTECHNIK GMBH WALTER GRAPHTEK 10/02/1991
K823116 INTERSPEC, INC. NEUROTRAC 12/07/1982
K870815 KONTRON INSTRUMENTS, INC. KONTRON E.E.G. MONITOR, SUPERMON MODULE 7265 02/01/1988
K924179 LAMA ENGINEERING, INC. EEG MODEL 24/32 06/22/1993
K904269 LEXICOR MEDICAL TECHNOLOGY, INC. NEUROSEARCH-24 OR NRS-24 06/04/1991
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
K920127 MEDELEC INTL. CORP. ELECTROENCEPHALOGRAPH RECORDING SYSTEM 06/10/1992
K922548 MEDELEC INTL. CORP. MEDELEC 2110 AND 2114 EEG 11/03/1992
K934670 MEDELEC LTD. DG 3P SYSTEM 05/25/1994
K964280 MEDELEC LTD. DG NERVUS 01/27/1997
K921485 MEDICAL SYSTEMS CORP. LA MONT VIDEO PATIENT MONITORING SYSTEM 10/22/1992
K173460 MemoryMD Inc. NeuroEEG 02/16/2018
K770246 MENNEN GREATBATCH ELECTONICS ISOLATED EEG AMPLIFIER MODULE 02/14/1977
K910945 MENNEN MEDICAL, INC. HORIZON 2000 EEG MONITORING OPTION 08/15/1991
K171384 Micromed S.P.A Micromed BRAIN QUICK system 02/01/2018
K863124 MICROTRONICS CORP. MODEL 8 EEG PREAMPLIFIER 11/18/1986
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
K914571 MOBERG MEDICAL, INC. NEUROTRAC II 01/30/1992
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
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
K180181 Natus Medical Incorporated DBA Excel_tech Ltd. (XLTEK) Natus Quantum 02/22/2018
K951507 NEUROCONCEPTS, INC. PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE 07/14/1995
K905435 NEUROCONCEPTS, INC. UNIQUANT 07/22/1991
K974495 NEUROCORP, LTD. NEUROAMP EEG AMPLIFIER 02/26/1998
K162681 Neuroelectrics Barcelona S.L.U. Enobio Wireless EEG 06/02/2017
K023771 NEUROSCAN SYNAMPS2 02/06/2003
K870263 NEUROSCIENCE, INC. NEUROMAPPER 1620 04/10/1987
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
K910279 NEW ENGLAND MEDICAL INSTRUMENTS, INC. MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER 09/04/1991
K850259 NICOLET BIOMEDICAL INSTRUMENTS ELECTROENCEPHALOGRAPH EEG 04/11/1985
K873535 NICOLET BIOMEDICAL INSTRUMENTS NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM 10/26/1987
K991054 NICOLET BIOMEDICAL, INC. BRAVO MULTI-MODALITY SYSTEM 11/03/1999
K971331 NICOLET BIOMEDICAL, INC. SATELLITE 06/25/1997
K921138 NICOLET INSTRUMENT CORP. NICOLET ULTRASOM ACQUISITION STATION 05/14/1993
K921927 NICOLET INSTRUMENT CORP. NICOLET VOYAGEUR 11/05/1992
K884537 NIHON KOHDEN AMERICA, INC. AE-800PA EEG MODULE 12/29/1988
K831324 NIHON KOHDEN AMERICA, INC. EEG 42/2P ELECTRO ENCEPHALOGRAPH 05/27/1983
K842714 NIHON KOHDEN AMERICA, INC. EEG-4300 W/OPTINAL ACCESS. EEG 4314 & 09/25/1984
K902550 NIHON KOHDEN AMERICA, INC. EEG-5400 SERIES 03/19/1991
K823140 NIHON KOHDEN AMERICA, INC. ELECTROENCEPHALOGRAPH 12/07/1982
K820066 NIHON KOHDEN AMERICA, INC. ELECTROENCEPHALOGRAPHS EEG-5208,5210 02/04/1982
K791150 NIHON KOHDEN AMERICA, INC. ELECTROENCEPHALOGRAPHS MODELS 7209,7213 09/12/1979
K802887 NIHON KOHDEN AMERICA, INC. MODEL EEG 4221 12/16/1980
K874796 NIHON KOHDEN AMERICA, INC. MODEL EEG 4400 WITH OPTIONAL ACCESSORIES 01/19/1988
K791233 NIHON KOHDEN AMERICA, INC. MODEL EEG-4214 ELECTROENCEPHALOGRAPH 09/12/1979
K791234 NIHON KOHDEN AMERICA, INC. MODEL EEG-4217 ELECTROENCEPHALOGRAPH 09/12/1979
K854663 NIHON KOHDEN AMERICA, INC. NEUROFAX 7310 SERIES (EEG) 08/20/1986
K915096 NIHON KOHDEN AMERICA, INC. NEUROFAX EEG 5532 03/11/1992
K113117 NIHON KOHDEN AMERICA, INC. NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX 03/22/2012
K944678 NIHON KOHDEN AMERICA, INC. NIHON KOHDEN ELECTROENCEPHALOGRAPH 05/22/1995
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
K781129 OXFORD MEDILOG, INC. ACCESSORY TO 4-24 RECORDER 08/31/1978
K850418 OXFORD MEDILOG, INC. BUSHEL OFF-HEAD PREAMPLIFIER 06/13/1985
K830295 OXFORD MEDILOG, INC. MEDILOG 9000 SYSTEM 03/24/1983
K904763 OXFORD MEDILOG, INC. MENTOR EEG SYSTEM 04/10/1991
K871500 OXFORD MEDILOG, INC. MODEL 5000 AMBULATORY MONITORING SYSTEM 07/01/1987
K860456 OXFORD MEDILOG, INC. MODEL 9000 RECORDING & ELECTROPHYSIOLOGICAL SYSTEM 08/11/1986
K930080 PHYSIOMETRIX, INC. E*NET NEUROMONITORING SYSTEM 10/19/1993
K962447 PHYSIOMETRIX, INC. EQUINOX DIGITAL EEG SYSTEM 12/12/1996
K953449 PHYSIOMETRIX, INC. MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS 10/12/1995
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
K802296 SIEMENS CORP. MINGOGRAF EEG10 10/03/1980
K802292 SIEMENS CORP. MINGOGRAF EEG21 10/03/1980
K932842 SPACELABS MEDICAL, INC. SPACELABS MEDICAL MODEL 90481 EEG MODULE 03/02/1994
K896942 SPACELABS, INC. SPACELABS MODEL 90480 EEG MODULE 03/08/1990
K083577 STELLATE SYSTEMS HARMONIE SYSTEM 08/29/2011
K903004 TECA, INC. EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH 11/15/1990
K896666 TECA, INC. P460, DG32 ELECTROENCEPHALOGRAPH 02/16/1990
K890881 TECA, INC. TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS 03/23/1989
K851232 TECA, INC. TECA MONTAGE II 06/13/1985
K863749 TECA, INC. TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH 10/06/1986
K010669 THURIS CORP. NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1 06/04/2001
K061908 VIASYS NEUROCARE NICOLETONE SYSTEM V32 AMPLIFIER 11/06/2006
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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