GWQ — Full-Montage Standard Electroencephalograph Class II
Classification Details
- Product Code
- GWQ
- Device Class
- Class II
- Regulation Number
- 882.1400
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260455 | zeto | New Wave System | March 13, 2026 |
| K233403 | zeto | Flexset System | April 30, 2024 |
| K231366 | bioserenity | Neuronaute Plus | November 9, 2023 |
| K221959 | neurofield | Q21 | August 31, 2023 |
| K231457 | spark neuro | SPARK Scan | August 18, 2023 |
| K221963 | cumulus neuroscience limited | Cumulus Functional Neurophysiology Platform | April 27, 2023 |
| K230073 | compumedics limited | Okti | February 9, 2023 |
| K223644 | bioserenity | Neuronaute with IceCap 2 & IceCap 2 Small | January 12, 2023 |
| K220056 | imedisync | iSyncWave | August 10, 2022 |
| K212788 | seer medical pty | Seer Home | June 16, 2022 |
| K213900 | wavi | WAVi SCAN EEG System and Accessories | May 6, 2022 |
| K193159 | corscience gmbh and co. kg | NeuroAmp II, NeuroAmp II.5s | December 30, 2020 |
| K202334 | bioserenity | Neuronaute | December 10, 2020 |
| K201819 | cadwell industries | Cadwell Apollo System | September 29, 2020 |
| K191492 | neurovirtual usa | Maxxi Position Sensor | April 24, 2020 |
| K191868 | ice neurosystems | iCEWav Neuromonitoring Platform | March 31, 2020 |
| K192753 | medeia | NeuralScan System | March 17, 2020 |
| K181466 | cadwell industries | Cadwell Zenith System | September 1, 2018 |
| K180269 | cadwell industries | Cadwell Apollo System | July 17, 2018 |
| K180290 | natus medical incorporated dba excel-tech ltd. (xltek) | Natus Brain Monitor Amplifier | June 14, 2018 |