FDA product code GWQ

Full-Montage Standard Electroencephalograph

Neurology·Class 2·21 CFR 882.1400
US regulatory classifications
US Product Code (FDA)
GWQ
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 882.1400
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Medical specialty
Neurology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
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

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About this record

Full-Montage Standard Electroencephalograph is a medical device type in the Neurology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.