ATLAS COMBO BOARD 31-0605-0117

GUDID 10850011306144

The ATLAS Combo Board combines the functionality of the ATLAS Hybrid Input Board and ATLAS DRS-36 Board onto a single board, meaning the Digital Reference Selection and Analog to Digital Conversion for 32 electrodes is combined into a single slot.

NEURALYNX, INC.

Electroencephalographic monitoring system, stationary

• Primary Device ID: 10850011306144
• NIH Device Record Key: f18a0497-1704-40ce-9ad6-08c17c62d113
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATLAS COMBO BOARD
• Version Model Number: ATLAS COMBO BOARD
• Catalog Number: 31-0605-0117
• Company DUNS: 933200842
• Company Name: NEURALYNX, INC.
• 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: 4065854542
• Email: support@neuralynx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10850011306144 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110967

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: 2020-03-06
• Device Publish Date: 2020-02-27

On-Brand Devices [ATLAS COMBO BOARD]

• 10850011306144: The ATLAS Combo Board combines the functionality of the ATLAS Hybrid Input Board and ATLAS DRS-3
• 00850011306147: The ATLAS Combo Board combines the functionality of the ATLAS Hybrid Input Board and ATLAS DRS-3