FDA Product Code
FDA Product Code GWQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1400
510(k) Clearances — 189 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261604 | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) | Neuroelectrics Barcelona S.L.U. | 2026-06-13 | Special | PDF ↗ |
| K260455 | New Wave System | Zeto, Inc. | 2026-03-13 | Special | PDF ↗ |
| K233403 | Flexset System | Zeto, Inc. | 2024-04-30 | Traditional | PDF ↗ |
| K231366 | Neuronaute Plus | Bioserenity Sas | 2023-11-09 | Traditional | PDF ↗ |
| K221959 | Q21 | Neurofield, Inc. | 2023-08-31 | Traditional | PDF ↗ |
| K231457 | SPARK Scan | Spark Neuro, Inc. | 2023-08-18 | Traditional | PDF ↗ |
| K221963 | Cumulus Functional Neurophysiology Platform | Cumulus Neuroscience Limited | 2023-04-27 | Traditional | PDF ↗ |
| K230073 | Okti | Compumedics Limited | 2023-02-09 | Traditional | PDF ↗ |
| K223644 | Neuronaute with IceCap 2 & IceCap 2 Small | Bioserenity | 2023-01-12 | Special | PDF ↗ |
| K220056 | iSyncWave | iMediSync, Inc. | 2022-08-10 | Traditional | PDF ↗ |
| K212788 | Seer Home | Seer Medical Pty, Ltd. | 2022-06-16 | Traditional | PDF ↗ |
| K213900 | WAVi SCAN EEG System and Accessories | Wavi Co. | 2022-05-06 | Traditional | PDF ↗ |
| K193159 | NeuroAmp II, NeuroAmp II.5s | Corscience GmbH & Co. KG | 2020-12-30 | Traditional | PDF ↗ |
| K202334 | Neuronaute | Bioserenity Sas | 2020-12-10 | Traditional | PDF ↗ |
| K201819 | Cadwell Apollo System | Cadwell Industries, Inc. | 2020-09-29 | Traditional | PDF ↗ |
| K191492 | Maxxi Position Sensor | Neurovirtual USA, Inc. | 2020-04-24 | Traditional | PDF ↗ |
| K191868 | iCEWav Neuromonitoring Platform | Ice Neurosystems, Inc. | 2020-03-31 | Traditional | PDF ↗ |
| K192753 | NeuralScan System | Medeia, Inc. | 2020-03-17 | Traditional | PDF ↗ |
| K181466 | Cadwell Zenith System | Cadwell Industries, Inc. | 2018-09-01 | Traditional | PDF ↗ |
| K180269 | Cadwell Apollo System | Cadwell Industries, Inc. | 2018-07-17 | Traditional | PDF ↗ |
| K180290 | Natus Brain Monitor Amplifier | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-06-14 | Traditional | PDF ↗ |
| K172271 | Trackit T4 EEG Amplifier | Lifelines , Ltd. | 2018-05-04 | Traditional | PDF ↗ |
| K172735 | WR19 System | Zeto, Inc. | 2018-04-17 | Traditional | PDF ↗ |
| K180181 | Natus Quantum | Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek) | 2018-02-22 | Special | PDF ↗ |
| K173460 | NeuroEEG | Memory MD, Inc. | 2018-02-16 | Traditional | PDF ↗ |
| K171384 | Micromed BRAIN QUICK system | Micromed S.P.A. | 2018-02-01 | Traditional | PDF ↗ |
| K170138 | NEURONAUTE | Bioserenity | 2017-12-26 | Traditional | PDF ↗ |
| K171781 | eVox System | Evoke Neuroscience, Inc. | 2017-12-13 | Traditional | PDF ↗ |
| K171124 | Nihon Kohden Wireless Input Unit WEE-1200 | Nihon Kohden Corporation | 2017-08-25 | Traditional | PDF ↗ |
| K170441 | ElectroTek | Mobilemedtek | 2017-06-05 | Traditional | PDF ↗ |
| K162681 | Enobio Wireless EEG | Neuroelectrics Barcelona S.L.U. | 2017-06-02 | Traditional | PDF ↗ |
| K163163 | XLTEK EMU40EX EEG Headbox | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2016-12-14 | Special | PDF ↗ |
| K162595 | Trex_HD | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2016-11-04 | Traditional | PDF ↗ |
| K150498 | Discovery 24 | Brainmaster Technologies, Inc. | 2016-01-26 | Traditional | PDF ↗ |
| K143233 | Mitsar-EEG | Mitsar Co., Ltd. | 2015-08-13 | Traditional | PDF ↗ |
| K143440 | Natus Quantum | Natus Medical Incorporated | 2015-04-20 | Traditional | PDF ↗ |
| K131335 | BWMINI EEG, BWMINIHST, BWMINI PSG | Neurovirtual USA, Inc. | 2015-02-03 | Traditional | PDF ↗ |
| K131266 | TREZ_HD | Excel-Tech Ltd. (Xltek) | 2014-02-14 | Traditional | PDF ↗ |
| K133355 | CADWELL FLEX EEG/PSG | Cadwell Industries, Inc. | 2014-01-29 | Traditional | PDF ↗ |
| K131383 | X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE | Advanced Brain Monitoring, Inc. | 2013-11-27 | Traditional | PDF ↗ |
| K122196 | CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY | Blackrock Neuromed, LLC | 2013-05-02 | Traditional | PDF ↗ |
| K120888 | PSG-1100 SLEEP DIAGNOSTIC SYSTEM | Nihon Kohden Corp. | 2012-11-09 | Special | PDF ↗ |
| K112817 | MICROEEG SYSTEM | Bio-Signal Group Corporation | 2012-06-19 | Traditional | PDF ↗ |
| K113117 | NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX | Nihon Kohden America, Inc. | 2012-03-22 | Special | PDF ↗ |
| K112353 | GEODESIC EEG MOBILE 100 (GEM 100) | Electrical Geodesics, Inc. | 2012-02-17 | Traditional | PDF ↗ |
| K112107 | BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS | Neurovirtual USA, Inc. | 2011-10-28 | Traditional | PDF ↗ |
| K083577 | HARMONIE SYSTEM | Stellate Systems | 2011-08-29 | Abbreviated | PDF ↗ |
| K110376 | PE-210AK SWITCH BOX | Nihon Kohden Corp. | 2011-07-29 | Traditional | PDF ↗ |
| K103129 | ENTROPY EASYFIT SENSOR | GE Healthcare | 2011-07-19 | Traditional | PDF ↗ |
| K101386 | VIGILANT EEG MONITOR MODEL VIGILANT 2.0 | Infinite Biomedical Technologies, LLC | 2010-07-30 | Special | PDF ↗ |
| K100683 | NEUROLINK IP MODEL: PK1117 | Natus Medical Incorporated | 2010-04-09 | Special | PDF ↗ |
| K093223 | COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG | Compumedics Limited | 2010-01-15 | Traditional | PDF ↗ |
| K081741 | NEUROLINK IP, MODEL PK1113 | Excel-Tech Ltd. (Xltek) | 2008-10-31 | Traditional | PDF ↗ |
| K081151 | COMPUMEDICS NEUVO | Compumedics USA, Ltd. | 2008-09-08 | Special | PDF ↗ |
| K071109 | SACS EEG WORKSTATION A7 | Sacs Medical AB | 2007-06-07 | Traditional | PDF ↗ |
| K061908 | NICOLETONE SYSTEM V32 AMPLIFIER | Viasys Neuro Care | 2006-11-06 | Abbreviated | PDF ↗ |
| K053386 | XLTEK EMU40 EEG HEADBOX, MODEL PK1072 | Excel Tech. , Ltd. | 2006-04-21 | Traditional | PDF ↗ |
| K051825 | COGNITRACE | Eemagine Medical Imaging Solutions GmbH | 2005-09-12 | Traditional | PDF ↗ |
| K042626 | NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM | Cyberkinetics, Inc. | 2005-03-28 | Traditional | PDF ↗ |
| K043309 | GEODESIC PHOTOGRAMMETRY SYSTEM | Electrical Geodesics, Incorporated | 2005-01-26 | Traditional | PDF ↗ |
| K042150 | XLTEK TREX MODEL#10309 | Excel Tech. , Ltd. | 2004-08-27 | Special | PDF ↗ |
| K033399 | GEODESIC EEG SYSTEM SERIES 100 | Electrical Geodesics, Incorporated | 2004-08-04 | Traditional | PDF ↗ |
| K040554 | ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256 | Manufacturing Technology, Inc. | 2004-07-16 | Abbreviated | PDF ↗ |
| K040360 | EMU128S, MODEL EX-NW-128S | Excel Tech. , Ltd. | 2004-03-12 | Special | PDF ↗ |
| K033978 | ADAM | Astro-Med, Inc. | 2004-02-18 | Traditional | PDF ↗ |
| K023771 | SYNAMPS2 | Neuroscan | 2003-02-06 | Abbreviated | PDF ↗ |
| K022785 | EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION | Axon Systems, Inc. | 2002-10-09 | Special | PDF ↗ |
| K021599 | 96 CHANNEL EEG HEADBOX MODEL EMU96 | Excel Tech. , Ltd. | 2002-08-13 | Traditional | PDF ↗ |
| K014146 | 84 CHANNEL EEG | Xltek | 2002-01-14 | Special | PDF ↗ |
| K014147 | 80 CHANNEL EEG | Xltek | 2002-01-14 | Special | PDF ↗ |
| K010997 | PAM-RL | Individual Monitoring Systems, Inc. | 2001-10-15 | Traditional | PDF ↗ |
| K012079 | GEODESIC EEG SYSTEM, MODEL 200 | Electrical Geodesics, Incorporated | 2001-09-19 | Traditional | PDF ↗ |
| K010697 | UNIQUE AMBULATORY EEG | Axon Systems, Inc. | 2001-06-06 | Traditional | PDF ↗ |
| K010669 | NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1 | Thuris Corp. | 2001-06-04 | Traditional | PDF ↗ |
| K011430 | ACTIWARE-PLMS | Mini-Mitter Co., Inc. | 2001-05-31 | Special | PDF ↗ |
| K010086 | REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED) | Excel Tech. , Ltd. | 2001-04-09 | Traditional | PDF ↗ |
| K010089 | REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED) | Excel Tech. , Ltd. | 2001-03-26 | Traditional | PDF ↗ |
| K010088 | REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED) | Excel Tech. , Ltd. | 2001-03-26 | Traditional | PDF ↗ |
| K010084 | REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP | Excel Tech. , Ltd. | 2001-03-16 | Traditional | PDF ↗ |
| K010150 | 64 CHANNEL EEG / MODEL NUMBER EX-NW-64 | Excel Tech. , Ltd. | 2001-02-09 | Special | PDF ↗ |
| K010091 | EEG WITH VIDEO, MODEL EX-NW | Excel Tech. , Ltd. | 2001-02-01 | Special | PDF ↗ |
| K002316 | PHOENIX DIGITAL EEG | Axon Systems, Inc. | 2000-10-26 | Traditional | PDF ↗ |
| K002570 | BIO-LOGIC CEEGRAPH NETLINK | Bio-Logic Systems Corp. | 2000-09-14 | Special | PDF ↗ |
| K000919 | 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128 | Excel Tech. , Ltd. | 2000-08-31 | Traditional | PDF ↗ |
| K001103 | WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED) | Excel Tech. , Ltd. | 2000-06-30 | Traditional | PDF ↗ |
| K000898 | EEG WITH VIDEO, MODEL EX-NW | Excel Tech. , Ltd. | 2000-04-14 | Special | PDF ↗ |
| K991054 | BRAVO MULTI-MODALITY SYSTEM | Nicolet Biomedical, Inc. | 1999-11-03 | Traditional | PDF ↗ |
| K992410 | ACTITRAC | Individual Monitoring Systems, Inc. | 1999-10-15 | Traditional | PDF ↗ |
| K991033 | ACTIWATCH-SCORE | Mini-Mitter Co., Inc. | 1999-06-23 | Traditional | PDF ↗ |
| K983533 | ACTIWATCH | Mini-Mitter Co., Inc. | 1999-03-23 | Traditional | PDF ↗ |
| K982479 | EXCEL AMBULATORY EEG | Excel Tech. , Ltd. | 1998-10-14 | Traditional | PDF ↗ |
| K980214 | EXCEL NEURO WORKS | Excel Tech. , Ltd. | 1998-04-21 | Traditional | PDF ↗ |
| K973883 | BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM | Bio-Logic Systems Corp. | 1998-03-05 | Traditional | PDF ↗ |
| K974495 | NEUROAMP EEG AMPLIFIER | Neurocorp, Ltd. | 1998-02-26 | Traditional | PDF ↗ |
| K971329 | CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM) | Ctf Systems, Inc. | 1997-11-20 | Traditional | PDF ↗ |
| K972202 | DEEG-LITE | Grass-Telefactor Product Group | 1997-07-23 | Traditional | PDF ↗ |
| K971331 | SATELLITE | Nicolet Biomedical, Inc. | 1997-06-25 | Traditional | PDF ↗ |
| K970942 | MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM | Physiometrix, Inc. | 1997-06-02 | Traditional | PDF ↗ |
| K970703 | GALILEO HALLEY | Biosound Esaote, Inc. | 1997-05-19 | Traditional | PDF ↗ |
| K964280 | DG NERVUS | Medelec , Ltd. | 1997-01-27 | Traditional | PDF ↗ |
Product code GWQ · Class II · Neurology. Data: openFDA.