Catalog Number

1121998

Brand Name

Sleepware

Version/Model Number

Sleepware G3 Software, (Japan Only) - 3

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 05, 2021

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

-

Product Code

OLZ

Product Code Name

Automatic event detection software for polysomnograph with electroencephalograph

Public Device Record Key

c23b2ea2-a0b2-4ab5-956a-f3939ba47b36

Public Version Date

March 05, 2021

Public Version Number

3

DI Record Publish Date

January 03, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-