ATLAS ANALOG ISOLATOR 31-0602-0029

GUDID 00850011306161

The ATLAS Analog Isolator is an optional accessory of the ATLAS Neurophysiology System that isolates 16 analog channels on the system.

NEURALYNX, INC.

Electroencephalographic monitoring system

• Primary Device ID: 00850011306161
• NIH Device Record Key: f904f4fd-273f-403b-abdc-e6fc392dd6d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATLAS ANALOG ISOLATOR
• Version Model Number: ATLAS ANALOG ISOLATOR
• Catalog Number: 31-0602-0029
• 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
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011306161 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-07-12
• Device Publish Date: 2020-01-15

On-Brand Devices [ATLAS ANALOG ISOLATOR]

• 10850011306168: The ATLAS Analog Isolator is an optional accessory of the ATLAS Neurophysiology System that isol
• 00850011306161: The ATLAS Analog Isolator is an optional accessory of the ATLAS Neurophysiology System that isol