COGNISION EEG/EP System H1000

GUDID B706H10000

COGNISION EEG/EP System. Includes headset, headset control unit, earphones, cables, and system case.

Neuronetrix Solutions, LLC

Electroencephalograph

• Primary Device ID: B706H10000
• NIH Device Record Key: cc1f5dea-ca15-433d-8396-6b497755c983
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COGNISION EEG/EP System
• Version Model Number: 3000
• Catalog Number: H1000
• Company DUNS: 117102035
• Company Name: Neuronetrix Solutions, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 502-561-9040
• Email: support@cognision.com
• Phone: 502-561-9040
• Email: support@cognision.com
• Phone: 502-561-9040
• Email: support@cognision.com
• Phone: 502-561-9040
• Email: support@cognision.com
• Phone: 502-561-9040
• Email: support@cognision.com
• Phone: 502-561-9040
• Email: support@cognision.com
• Phone: 502-561-9040
• Email: support@cognision.com
• Phone: 502-561-9040
• Email: support@cognision.com
• Phone: 502-561-9040
• Email: support@cognision.com
• Phone: 502-561-9040
• Email: support@cognision.com
• Phone: 502-561-9040
• Email: support@cognision.com
• Phone: 502-561-9040
• Email: support@cognision.com
• Phone: 502-561-9040
• Email: support@cognision.com
• Phone: 502-561-9040
• Email: support@cognision.com
• Phone: 502-561-9040
• Email: support@cognision.com
• Phone: 502-561-9040
• Email: support@cognision.com
• Phone: 502-561-9040
• Email: support@cognision.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B706H10000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141316

FDA Product Code

• OMC: Reduced- Montage Standard Electroencephalograph

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: 2025-03-20
• Device Publish Date: 2025-03-12