GWQ · Full-Montage Standard Electroencephalograph
Neurology · 21 CFR 882.1400 · Class 2
Overview
| Product Code | GWQ |
|---|---|
| Device Name | Full-Montage Standard Electroencephalograph |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 189)
Showing 20 most recent of 189 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K261604 | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) | Neuroelectrics Barcelona S.L.U. | Jun 13, 2026 | SESE |
| K260455 | New Wave System | Zeto, Inc. | Mar 13, 2026 | SESE |
| K233403 | Flexset System | Zeto, Inc. | Apr 30, 2024 | SESE |
| K231366 | Neuronaute Plus | Bioserenity Sas | Nov 9, 2023 | SESE |
| K221959 | Q21 | Neurofield, Inc. | Aug 31, 2023 | SESE |
| K231457 | SPARK Scan | Spark Neuro, Inc. | Aug 18, 2023 | SESE |
| K221963 | Cumulus Functional Neurophysiology Platform | Cumulus Neuroscience Limited | Apr 27, 2023 | SESE |
| K230073 | Okti | Compumedics Limited | Feb 9, 2023 | SESE |
| K223644 | Neuronaute with IceCap 2 & IceCap 2 Small | Bioserenity | Jan 12, 2023 | SESE |
| K220056 | iSyncWave | iMediSync, Inc. | Aug 10, 2022 | SESE |
| K212788 | Seer Home | Seer Medical Pty, Ltd. | Jun 16, 2022 | SESE |
| K213900 | WAVi SCAN EEG System and Accessories | Wavi Co. | May 6, 2022 | SESE |
| K193159 | NeuroAmp II, NeuroAmp II.5s | Corscience GmbH & Co. KG | Dec 30, 2020 | SESE |
| K202334 | Neuronaute | Bioserenity Sas | Dec 10, 2020 | SESE |
| K201819 | Cadwell Apollo System | Cadwell Industries, Inc. | Sep 29, 2020 | SESE |
| K191492 | Maxxi Position Sensor | Neurovirtual USA, Inc. | Apr 24, 2020 | SESE |
| K191868 | iCEWav Neuromonitoring Platform | Ice Neurosystems, Inc. | Mar 31, 2020 | SESE |
| K192753 | NeuralScan System | Medeia, Inc. | Mar 17, 2020 | SESE |
| K181466 | Cadwell Zenith System | Cadwell Industries, Inc. | Sep 1, 2018 | SESE |
| K180269 | Cadwell Apollo System | Cadwell Industries, Inc. | Jul 17, 2018 | SESE |
Top Applicants
- Excel Tech. , Ltd. — 15 clearances
- Nihon Kohden America, Inc. — 15 clearances
- Del Mar Avionics — 7 clearances
- Oxford Medilog, Inc. — 6 clearances
- Bio-Logic Systems Corp. — 5 clearances
