ATLAS NK HEADBOX 31-0601-0017

GUDID 10850011306069

The ATLAS NK Headbox allows JE-125A, JE-225A, JE-226A, JE-227A, and JE-228A Mini Flat Junction Boxes by Nihon Kohden Corporation (NKC) to interface with the ATLAS Neurophysiology System by Neuralynx and JE-120A or JE-212A Amplifier by Nihon Kohden Corporation through the ATLAS NKSS Cable (also by Neuralynx).

NEURALYNX, INC.

Electroencephalographic monitoring system, stationary

• Primary Device ID: 10850011306069
• NIH Device Record Key: 011fd947-7d77-4f0d-b8b0-2c8fb5066d89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATLAS NK HEADBOX
• Version Model Number: ATLAS NK HEADBOX
• Catalog Number: 31-0601-0017
• 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	10850011306069 [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 NK HEADBOX]

• 10850011306069: The ATLAS NK Headbox allows JE-125A, JE-225A, JE-226A, JE-227A, and JE-228A Mini Flat Junction B
• 00850011306062: The ATLAS NK Headbox allows JE-125A, JE-225A, JE-226A, JE-227A, and JE-228A Mini Flat Junction B