Axon - Neurofeedback Kit - Smallincludes Axon EEG - EXSURGO LIMITED

Duns Number:594916540

Device Description: Neurofeedback Kit - Smallincludes Axon EEG headset - Small, Tablet with Axon Neurofeedback Neurofeedback Kit - Smallincludes Axon EEG headset - Small, Tablet with Axon Neurofeedback Software Application

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More Product Details

Catalog Number

100140

Brand Name

Axon

Version/Model Number

Small

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

-

Product Code Details

Product Code

HCC

Product Code Name

Device, Biofeedback

Device Record Status

Public Device Record Key

356ab0ba-2e33-4b03-b847-67493bf1b393

Public Version Date

August 23, 2021

Public Version Number

1

DI Record Publish Date

August 13, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EXSURGO LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7