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FDA PRODUCT CODE · CLASS II

GWQ — Full-Montage Standard Electroencephalograph

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

DEVICE CLASS
Class II
REGULATION
21 CFR 882.1400
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES

Recent clearances

K261604Neuroelectrics Barcelona S.L.U. · 510k2026-06-13
K260455Zeto, Inc. · 510k2026-03-13

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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