cognitrace

GUDID B195SC100

eeg recording and review

eemagine Medical Imaging Solutions GmbH

Electroencephalographic monitoring system, stationary

• Primary Device ID: B195SC100
• NIH Device Record Key: 660f6a45-0a82-4cbc-8343-c4acba3ca544
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cognitrace
• Version Model Number: SC-100
• Company DUNS: 313152485
• Company Name: eemagine Medical Imaging Solutions GmbH
• Device Count: 1
• DM Exempt: false
• 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: 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: +493029048404
• Email: support@eemagine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B195SC100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051825

FDA Product Code

• GWQ: Full-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: 2020-05-08
• Device Publish Date: 2020-04-30

On-Brand Devices [cognitrace]

• B195SC100: eeg recording and review
• B195LC107: cognitrace component
• B195LC106: cognitrace component
• B195LC105: cognitrace component
• B195LC104: cognitrace component
• B195LC100: cognitrace component