NEBA Compact EEG System

GUDID 00863414000314

Neuropsychiatric interpretive electroencephalograph assessment aid. Uses a patient's electroencephalograph (eeg) to provide an interpretation of the patient's neuropsychiatric condition.It is also used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis

NEBA HEALTH, LLC

Electroencephalograph

• Primary Device ID: 00863414000314
• NIH Device Record Key: 2ab7115d-0596-45f6-87de-9100bc6a053c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEBA Compact EEG System
• Version Model Number: 7200101
• Company DUNS: 605190313
• Company Name: NEBA HEALTH, LLC
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863414000314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN110019

FDA Product Code

• NCG: Neuropsychiatric Interpretative Electroencephalograph Assessment Aid

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: 2016-10-03