EEG NeuroAmp II

GUDID 04251341900047

Option Temperature Sensor pIRx3

CORSCIENCE GmbH & Co. KG

Biofeedback system

• Primary Device ID: 04251341900047
• NIH Device Record Key: 948d6953-a62d-40a5-a657-ff86ffc3565a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EEG NeuroAmp II
• Version Model Number: CS10289
• Company DUNS: 333427776
• Company Name: CORSCIENCE GmbH & Co. KG
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251341900047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073557

FDA Product Code

• HCC: Device, Biofeedback

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-22

On-Brand Devices [EEG NeuroAmp II]

• 04251341900047: Option Temperature Sensor pIRx3
• 04251341900023: CS10137-02
• 04251341900016: CS10137