FDA Product Code 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
Leading manufacturers include Zeto, Inc., Bioserenity and Compumedics Limited.
FDA 510(k) Cleared Full-montage Standard Electroencephalograph Devices (Product Code GWQ)
About Product Code GWQ - Regulatory Context
510(k) Submission Activity
188 total 510(k) submissions under product code GWQ since 1977, with 188 receiving FDA clearance (average review time: 145 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 9 in the prior period.
FDA Review Time
Recent submissions under GWQ have taken an average of 30 days to reach a decision - down from 145 days historically, suggesting improved FDA processing for this classification.
GWQ devices are reviewed by the Neurology panel. Browse all Neurology devices →