Catalog Number

-

Brand Name

NeuroEDUCATOR

Version/Model Number

PL-21-1000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K854277

Product Code

HCC

Product Code Name

Device, Biofeedback

Public Device Record Key

4640e2c9-a4ca-4b90-9d98-b60eb86ae149

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-