Catalog Number

RS-0115

Brand Name

Blackrock NeuroPort Biopotential Signal Processing System

Version/Model Number

7.0.4

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

K090957

Product Code

GWL

Product Code Name

Amplifier, Physiological Signal

Public Device Record Key

4d0573f4-6d89-4b66-8d89-c4f9b2f14011

Public Version Date

July 12, 2019

Public Version Number

2

DI Record Publish Date

September 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-