ATLAS-HS-10-CHET-A 1.0 HS-10-CHET-A 1.0

GUDID 00850011306024

The HS-10-CHET-A 1.0 is a clinical headstage that allows one Ad-Tech Tail Electrode (usually consisting of up to 9 electrodes) to interface with the ATLAS Neurophysiology System.

NEURALYNX, INC.

Electroencephalographic monitoring system, stationary

• Primary Device ID: 00850011306024
• NIH Device Record Key: 6b9355b6-ffa6-470c-982a-bab0ccfe20cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATLAS-HS-10-CHET-A 1.0
• Version Model Number: 1.0
• Catalog Number: HS-10-CHET-A 1.0
• 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: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011306024 [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: 2022-09-27
• Device Publish Date: 2022-09-19

Devices Manufactured by NEURALYNX, INC.

• 00850011306734 - Global Reference Module 1: 2024-03-26 The Global Reference Module provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference
• 00850011306208 - ATLAS TOPHAT Adapter Cable: 2023-07-13 The ATLAS TOPHAT Adapter cable allows signals from a Micromed JB TOPHAT electrode interface to be recorded by the ATLAS Neurophy
• 00850011306215 - ATLAS-HS-36-CHET-A9: 2023-07-13 The ATLAS-HS-36-CHET-A9 is a clinical headstage that allows four X 9 contact Adtech electrode connectors to interface with the A
• 00850011306222 - ATLAS-HS-36-CHET-IDC10: 2023-07-13 The ATLAS-HS-36-CHET-IDC10 is a clinical headstage that allows four X 3M 10 Pin Receptacle Connector (e.g. 8510-4500PL) connect
• 00850011306246 - ATLAS MICROMED JB INTERFACE: 2023-07-13 The ATLAS MICROMED JB INTERFACE is a buffered interface between Micromed Jackbox and ATLAS. The ATLAS MICROMED JB INTERFACE use
• 00850011306277 - Modular Electrode Interface-PM10: 2023-07-13 Modular Electrode Interface for connecting 10 contact PMT MINI CONNECTOR to Modular Headstage-36 which is connected to the ATLAS
• 00850011306284 - Modular Electrode Interface-PM16: 2023-07-13 Modular Electrode Interface for connecting 16 contact PMT MINI CONNECTOR to Modular Headstage-36 which is connected to the ATLAS
• 00850011306321 - ATLAS HDSS: 2023-07-13 The ATLAS High Density Signal Splitter (HDSS) is an adapter that allows signals from an electrode interface to be recorded by no