Catalog Number

-

Brand Name

SOMNOscreen HD EEG32 with Camera

Version/Model Number

NGDV741U

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

K071556

Product Code

-

Product Code Name

-

Public Device Record Key

00b3066d-17ba-4021-87ae-9471fabfdc34

Public Version Date

April 22, 2019

Public Version Number

1

DI Record Publish Date

April 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-