Enobio Dx

Basic Information

• Brand Name: Enobio Dx
• Primary DI: 18436612820276
• Version / Model: Enobio Dx 20
• Company Name: NEUROELECTRICS BARCELONA SL
• Labeler DUNS: 463756944
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-06
• Public Version: 1
• Public Version Date: 2023-09-14
• Public Version Status: New
• Public Device Record Key: 65a93674-3559-47b6-89f8-2ba92a2bc8fa

Device Description

Enobio Dx is a wireless battery-operated and portable electrophysiology sensor system for the recording of the electroencephalogram (EEG). It has been designated for use in a clinical environment or hospital. Enobio Dx use must be controlled by specialized medical personnel able to guarantee the correct recording.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GWQ	Full-Montage Standard Electroencephalograph	Neurology	882.1400	2
GWL	Amplifier, Physiological Signal	Neurology	882.1835	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38736	Electroencephalographic monitoring system	An electrically-powered device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function, typically in an examination room or intensive care unit (ICU) [bedside]; it may also monitor additional physiological parameters [e.g., electromyogram (EMG), respiration wave forms, blood pressure, haemoglobin oxygen saturation (SpO2)] in relation to EEG. It typically includes a control unit, electrodes, and components (e.g., amplifier, cables, probes). It may include data interpretation and/or telemetry features.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	18436612820276	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K162681	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 101.3 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 15 – 93 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 101.3 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 15 – 93 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius