ENOBIO - Enobio is a Wireless EEG, performs - NEUROELECTRICS BARCELONA SL

Duns Number:463756944

Device Description: Enobio is a Wireless EEG, performs electroencephalographic measures with non-invasive tech Enobio is a Wireless EEG, performs electroencephalographic measures with non-invasive technology.Enobio 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 use must be controlled by specialized medical personnel able to guarantee the correct recording.

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More Product Details

Catalog Number

-

Brand Name

ENOBIO

Version/Model Number

WF

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GWL

Product Code Name

Amplifier, Physiological Signal

Device Record Status

Public Device Record Key

ab460f7d-0e13-4410-93a6-e4821c3dc261

Public Version Date

June 11, 2020

Public Version Number

2

DI Record Publish Date

June 21, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEUROELECTRICS BARCELONA SL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1