Catalog Number

-

Brand Name

Esprit Nova

Version/Model Number

v 1.1

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)

-

FDA Premarket Submission

K182227

Product Code

OLZ

Product Code Name

Automatic Event Detection Software For Polysomnograph With Electroencephalograph

Public Device Record Key

708af24f-20ca-493a-937c-38d1f4b70992

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

December 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-