Catalog Number

-

Brand Name

ScanVision electrodes

Version/Model Number

PB-212

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

Yes

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

K123399,K123399,K123399,K123399

Product Code

HCC

Product Code Name

Device, Biofeedback

Public Device Record Key

ed4be987-96db-4d9b-9739-223c7df8e8e7

Public Version Date

January 18, 2021

Public Version Number

4

DI Record Publish Date

December 13, 2016

Package DI Number

00853818007248

Quantity per Package

12

Contains DI Package

00853818007231

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box