Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1400](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1400) → GWQ — Full-Montage Standard Electroencephalograph # GWQ · Full-Montage Standard Electroencephalograph _Neurology · 21 CFR 882.1400 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ ## Overview - **Product Code:** GWQ - **Device Name:** Full-Montage Standard Electroencephalograph - **Regulation:** [21 CFR 882.1400](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1400) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **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 188) Showing 20 most recent of 188 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260455](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K260455.md) | New Wave System | Zeto, Inc. | Mar 13, 2026 | SESE | | [K233403](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K233403.md) | Flexset System | Zeto, Inc. | Apr 30, 2024 | SESE | | [K231366](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K231366.md) | Neuronaute Plus | Bioserenity Sas | Nov 9, 2023 | SESE | | [K221959](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K221959.md) | Q21 | Neurofield, Inc. | Aug 31, 2023 | SESE | | [K231457](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K231457.md) | SPARK Scan | Spark Neuro, Inc. | Aug 18, 2023 | SESE | | [K221963](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K221963.md) | Cumulus Functional Neurophysiology Platform | Cumulus Neuroscience Limited | Apr 27, 2023 | SESE | | [K230073](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K230073.md) | Okti | Compumedics Limited | Feb 9, 2023 | SESE | | [K223644](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K223644.md) | Neuronaute with IceCap 2 & IceCap 2 Small | Bioserenity | Jan 12, 2023 | SESE | | [K220056](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K220056.md) | iSyncWave | iMediSync, Inc. | Aug 10, 2022 | SESE | | [K212788](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K212788.md) | Seer Home | Seer Medical Pty, Ltd. | Jun 16, 2022 | SESE | | [K213900](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K213900.md) | WAVi SCAN EEG System and Accessories | Wavi Co. | May 6, 2022 | SESE | | [K193159](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K193159.md) | NeuroAmp II, NeuroAmp II.5s | Corscience GmbH & Co. KG | Dec 30, 2020 | SESE | | [K202334](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K202334.md) | Neuronaute | Bioserenity Sas | Dec 10, 2020 | SESE | | [K201819](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K201819.md) | Cadwell Apollo System | Cadwell Industries, Inc. | Sep 29, 2020 | SESE | | [K191492](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K191492.md) | Maxxi Position Sensor | Neurovirtual USA, Inc. | Apr 24, 2020 | SESE | | [K191868](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K191868.md) | iCEWav Neuromonitoring Platform | Ice Neurosystems, Inc. | Mar 31, 2020 | SESE | | [K192753](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K192753.md) | NeuralScan System | Medeia, Inc. | Mar 17, 2020 | SESE | | [K181466](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K181466.md) | Cadwell Zenith System | Cadwell Industries, Inc. | Sep 1, 2018 | SESE | | [K180269](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K180269.md) | Cadwell Apollo System | Cadwell Industries, Inc. | Jul 17, 2018 | SESE | | [K180290](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K180290.md) | Natus Brain Monitor Amplifier | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Jun 14, 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 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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