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 |