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GWQ — Full-Montage Standard Electroencephalograph Class II

FDA Device Classification

FDA product code GWQ covers "Full-Montage Standard Electroencephalograph", a Class II medical device regulated under 21 CFR 882.1400. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.

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-NumberApplicantDevice NameDate
K261604neuroelectrics barcelona s.l.uEnobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)June 13, 2026
K260455zetoNew Wave SystemMarch 13, 2026
K233403zetoFlexset SystemApril 30, 2024
K231366bioserenityNeuronaute PlusNovember 9, 2023
K221959neurofieldQ21August 31, 2023
K231457spark neuroSPARK ScanAugust 18, 2023
K221963cumulus neuroscience limitedCumulus Functional Neurophysiology PlatformApril 27, 2023
K230073compumedics limitedOktiFebruary 9, 2023
K223644bioserenityNeuronaute with IceCap 2 & IceCap 2 SmallJanuary 12, 2023
K220056imedisynciSyncWaveAugust 10, 2022
K212788seer medical ptySeer HomeJune 16, 2022
K213900waviWAVi SCAN EEG System and AccessoriesMay 6, 2022
K193159corscience gmbh and co. kgNeuroAmp II, NeuroAmp II.5sDecember 30, 2020
K202334bioserenityNeuronauteDecember 10, 2020
K201819cadwell industriesCadwell Apollo SystemSeptember 29, 2020
K191492neurovirtual usaMaxxi Position SensorApril 24, 2020
K191868ice neurosystemsiCEWav Neuromonitoring PlatformMarch 31, 2020
K192753medeiaNeuralScan SystemMarch 17, 2020
K181466cadwell industriesCadwell Zenith SystemSeptember 1, 2018
K180269cadwell industriesCadwell Apollo SystemJuly 17, 2018

FDA data resources