Catalog Number

1082463

Brand Name

Sleepware

Version/Model Number

Sleepware G3 Software, Multi-Lingual - 3

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)

Yes

FDA Premarket Submission

-

Product Code

OLZ

Product Code Name

Automatic event detection software for polysomnograph with electroencephalograph

Public Device Record Key

00f5f4dd-0a3e-4eb0-8b6f-742b66b28040

Public Version Date

March 05, 2021

Public Version Number

3

DI Record Publish Date

October 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-