Product code GWQ
- Device name
- Full-Montage Standard Electroencephalograph
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.1400
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- 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
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260455 | New Wave System | Zeto, Inc. | 2026-03-13 |
| K233403 | Flexset System | Zeto, Inc. | 2024-04-30 |
| K231366 | Neuronaute Plus | Bioserenity Sas | 2023-11-09 |
| K221959 | Q21 | Neurofield, Inc. | 2023-08-31 |
| K231457 | SPARK Scan | Spark Neuro, Inc. | 2023-08-18 |
| K221963 | Cumulus Functional Neurophysiology Platform | Cumulus Neuroscience Limited | 2023-04-27 |
| K230073 | Okti | Compumedics Limited | 2023-02-09 |
| K223644 | Neuronaute with IceCap 2 & IceCap 2 Small | Bioserenity | 2023-01-12 |
| K220056 | iSyncWave | iMediSync, Inc. | 2022-08-10 |
| K212788 | Seer Home | Seer Medical Pty, Ltd. | 2022-06-16 |
| K213900 | WAVi SCAN EEG System and Accessories | Wavi Co. | 2022-05-06 |
| K193159 | NeuroAmp II, NeuroAmp II.5s | Corscience GmbH & Co. KG | 2020-12-30 |
| K202334 | Neuronaute | Bioserenity Sas | 2020-12-10 |
| K201819 | Cadwell Apollo System | Cadwell Industries, Inc. | 2020-09-29 |
| K191492 | Maxxi Position Sensor | Neurovirtual USA, Inc. | 2020-04-24 |
| K191868 | iCEWav Neuromonitoring Platform | Ice Neurosystems, Inc. | 2020-03-31 |
| K192753 | NeuralScan System | Medeia, Inc. | 2020-03-17 |
| K181466 | Cadwell Zenith System | Cadwell Industries, Inc. | 2018-09-01 |
| K180269 | Cadwell Apollo System | Cadwell Industries, Inc. | 2018-07-17 |
| K180290 | Natus Brain Monitor Amplifier | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-06-14 |
| K172271 | Trackit T4 EEG Amplifier | Lifelines , Ltd. | 2018-05-04 |
| K172735 | WR19 System | Zeto, Inc. | 2018-04-17 |
| K180181 | Natus Quantum | Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek) | 2018-02-22 |
| K173460 | NeuroEEG | Memory MD, Inc. | 2018-02-16 |
| K171384 | Micromed BRAIN QUICK system | Micromed S.P.A. | 2018-02-01 |
| K170138 | NEURONAUTE | Bioserenity | 2017-12-26 |
| K171781 | eVox System | Evoke Neuroscience, Inc. | 2017-12-13 |
| K171124 | Nihon Kohden Wireless Input Unit WEE-1200 | Nihon Kohden Corporation | 2017-08-25 |
| K170441 | ElectroTek | Mobilemedtek | 2017-06-05 |
| K162681 | Enobio Wireless EEG | Neuroelectrics Barcelona S.L.U. | 2017-06-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08690020003062 | BrainView NeuralScan | Medeia, Inc. | 2025-02-05 |
| 08056446900680 | Neurotravel LIGHT Base Unit | EB NEURO SPA | 2024-12-04 |
| 08056446901335 | BE PLUS PRO [FULL] | EB NEURO SPA | 2024-12-04 |
| 08056446901328 | BE PLUS PRO [STANDARD] | EB NEURO SPA | 2024-12-04 |
| 08056446901311 | BE PLUS PRO [LIGHT] | EB NEURO SPA | 2024-12-04 |
| 08056446900932 | BE PLUS PRO Battery Pack | EB NEURO SPA | 2024-12-04 |
| 08056446900925 | BE PLUS PRO ADVANCED | EB NEURO SPA | 2024-12-04 |
| 08056446900918 | BE PLUS PRO FULL | EB NEURO SPA | 2024-12-04 |
| 08056446900901 | BE PLUS PRO STANDARD | EB NEURO SPA | 2024-12-04 |
| 08056446900895 | BE PLUS PRO LIGHT | EB NEURO SPA | 2024-12-04 |
| 08056446900673 | Neurotravel LIGHT | EB NEURO SPA | 2024-12-04 |
| 08056446901342 | BE PLUS PRO [ADVANCED] | EB NEURO SPA | 2024-12-04 |
| 09342451002112 | Siesta | Compumedics Usa, Inc. | 2020-12-16 |
| 09342451001788 | Siesta | Compumedics Usa, Inc. | 2020-12-15 |
| 08056446900642 | Galileo NT Line Software | EB NEURO SPA | 2020-05-25 |
| 08056446900055 | BE Micro Headbox | EB NEURO SPA | 2019-04-02 |
| 08056446900024 | BE Micro USB BRIDGE | EB NEURO SPA | 2019-04-02 |
| 08056446900949 | BE Micro 21 CH MONO PLUG-IN HEADBOX | EB NEURO SPA | 2019-04-02 |
| 08056446900956 | BE Micro PLUG-IN HEADBOX 19 CH MONO+2CH BIPOL | EB NEURO SPA | 2019-04-02 |
| 08056446900000 | BE Micro | EB NEURO SPA | 2019-04-01 |
| 08033928120897 | Micromed | MICROMED SPA | 2018-05-21 |
| 08033928120958 | Micromed | MICROMED SPA | 2018-05-21 |
| 08033928120903 | Micromed | MICROMED SPA | 2018-05-21 |
| 08033928120910 | micromed | MICROMED SPA | 2018-03-21 |
| 08033928120880 | micromed | MICROMED SPA | 2018-03-21 |
| 09342451001269 | Compumedics Grael | COMPUMEDICS LIMITED | 2016-11-29 |
| 09342451001245 | Compumedics Grael | COMPUMEDICS LIMITED | 2016-11-17 |
| 09342451001283 | Compumedics Grael | COMPUMEDICS LIMITED | 2016-11-17 |
| 09342451001290 | Compumedics Grael | COMPUMEDICS LIMITED | 2016-11-17 |
| 10841983101530 | NA | NIHON KOHDEN AMERICA, INC. | 2016-09-19 |