Catalog Number

2606

Brand Name

R-40 (24)

Version/Model Number

Amp + WI-FI Kit

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

K151600

Product Code

GWL

Product Code Name

Amplifier, Physiological Signal

Public Device Record Key

aa39534c-c3dd-4fed-87f1-2a17e51ffd11

Public Version Date

February 04, 2020

Public Version Number

1

DI Record Publish Date

January 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-