ATLAS HC HEADBOX 31-0601-0010

GUDID 10850011306052

The ATLAS HC Headbox is a clinical headbox that allows a CA-105 waveguard™ EEG Cap by ANT Neuro to interface with the ATLAS Neurophysiology System by Neuralynx.

NEURALYNX, INC.

Electroencephalographic monitoring system, stationary

• Primary Device ID: 10850011306052
• NIH Device Record Key: f8578454-3d30-4e5a-86bf-8e4abbcc83b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATLAS HC HEADBOX
• Version Model Number: ATLAS HC HEADBOX
• Catalog Number: 31-0601-0010
• 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	10850011306052 [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 HC HEADBOX]

• 10850011306052: The ATLAS HC Headbox is a clinical headbox that allows a CA-105 waveguard™ EEG Cap by ANT Neur
• 00850011306055: The ATLAS HC Headbox is a clinical headbox that allows a CA-105 waveguard™ EEG Cap by ANT Neur