Catalog Number

-

Brand Name

Sensor, EEG FLEX/PRO

Version/Model Number

SA9305M

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K903497

Product Code

HCC

Product Code Name

Device, Biofeedback

Public Device Record Key

6f9837b0-9a63-4fe8-b876-5aa250f63f22

Public Version Date

November 20, 2019

Public Version Number

4

DI Record Publish Date

August 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-