GWQ

Full-Montage Standard Electroencephalograph

Product code
GWQ
Device name
Full-Montage Standard Electroencephalograph
Device class
Class 2
21 CFR
21 CFR 882.1400
Medical specialty
Neurology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
4
Summaries archived here
4 (direct download)
510(k) clearances (all years, FDA)
189 (all years; only the last 3 years are listed here)

FDA classification 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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2026-06-13.

NumberDecision dateApplicantDevice nameSummary
K2616042026-06-13Neuroelectrics Barcelona S.L.U.Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);EnoPDF
K2604552026-03-13Zeto, Inc.New Wave SystemPDF
K2334032024-04-30Zeto, Inc.Flexset SystemPDF
K2313662023-11-09Bioserenity SasNeuronaute PlusPDF

4 summaries are archived here for direct download.

Official FDA classification page: GWQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).