Catalog Number

5201PRO

Brand Name

g.Nautilus PRO

Version/Model Number

32-Channel-CSP Sahara

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K171669

Product Code

GWL

Product Code Name

Amplifier, Physiological Signal

Public Device Record Key

804133fc-22d7-460c-bab5-ad687189dfda

Public Version Date

December 02, 2020

Public Version Number

4

DI Record Publish Date

November 23, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-