Galileo NT Line Software - Software for EEG, EMG, EP and other applications - EB NEURO SPA

Duns Number:339182263

Device Description: Software for EEG, EMG, EP and other applications based on acquiring, processing and analyz Software for EEG, EMG, EP and other applications based on acquiring, processing and analyzing of biological electrical signals. Identifier (8012) contains the software version.

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More Product Details

Catalog Number

-

Brand Name

Galileo NT Line Software

Version/Model Number

B8640053000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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

K142064

Product Code Details

Product Code

GWE

Product Code Name

Stimulator, Photic, Evoked Response

Device Record Status

Public Device Record Key

bdd6ca75-8c5a-445f-adda-22b303974d93

Public Version Date

June 02, 2020

Public Version Number

1

DI Record Publish Date

May 25, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EB NEURO SPA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 67