Catalog Number

-

Brand Name

EnsoSleep

Version/Model Number

01.1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K162627

Product Code

OLZ

Product Code Name

Automatic Event Detection Software For Polysomnograph With Electroencephalograph

Public Device Record Key

7eac5f4c-f808-4474-8bd5-9b9dd4055e6d

Public Version Date

December 11, 2019

Public Version Number

5

DI Record Publish Date

July 19, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-