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510(k) Data Aggregation
K Number
K203331Device Name
Quick-20m
Manufacturer
CGX, LLC
Date Cleared
2021-05-20
(189 days)
Product Code
GWL, GXY
Regulation Number
882.1835Why did this record match?
Applicant Name (Manufacturer) :
CGX, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quick-20m is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
Device Description
The Quick-20m is a wireless, battery-operated 10-20 montage EEG headset utilizing dry sensor technology. The headset provides an integrated approach to the wireless acquisition of EEG signals. A seated patient is free to exhibit natural movements while real-time data is collected. The Quick-20m includes advanced amplification and shielding to reject ambient electrical noise.
The headset obtains high-quality EEG with minimal scalp preparation. Patented mechanisms and a range of replaceable dry sensors align to various head shapes and sizes, maintaining sensor positions in a standard 10-20 layout. EEG channels are digitized with 24 bits of resolution at 500 Hz. The Quick-20m is suitable for general-purpose EEG.
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