Catalog Number

502-0206

Brand Name

SleepView RIP Belt Interface

Version/Model Number

SleepView

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

K042039

Product Code

GWQ

Product Code Name

Full-Montage Standard Electroencephalograph

Public Device Record Key

b88986e0-9f6e-411d-9532-dcb371f0ed49

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 23, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-