Quick-20m SYS-0001-D

GUDID 00860009903715

The Quick-20m is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.

CGX, LLC

Multiple physiological signal amplifier

• Primary Device ID: 00860009903715
• NIH Device Record Key: 80f80a86-ddf9-4e4d-b3e4-5a8fa3ce43a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quick-20m
• Version Model Number: SYS-0001-D
• Catalog Number: SYS-0001-D
• Company DUNS: 117158699
• Company Name: CGX, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8588649400
• Email: support@cgxsystems.com
• Phone: 8588649400
• Email: support@cgxsystems.com
• Phone: 8588649400
• Email: support@cgxsystems.com
• Phone: 8588649400
• Email: support@cgxsystems.com
• Phone: 8588649400
• Email: support@cgxsystems.com
• Phone: 8588649400
• Email: support@cgxsystems.com
• Phone: 8588649400
• Email: support@cgxsystems.com
• Phone: 8588649400
• Email: support@cgxsystems.com
• Phone: 8588649400
• Email: support@cgxsystems.com
• Phone: 8588649400
• Email: support@cgxsystems.com
• Phone: 8588649400
• Email: support@cgxsystems.com
• Phone: 8588649400
• Email: support@cgxsystems.com
• Phone: 8588649400
• Email: support@cgxsystems.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009903715 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203331

FDA Product Code

• GWL: Amplifier, Physiological Signal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-07
• Device Publish Date: 2025-09-29