Catalog Number

1304

Brand Name

Trackit Sleepwalker

Version/Model Number

MK3 + SaO2 + BT

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

K010460

Product Code

OLV

Product Code Name

Standard Polysomnograph With Electroencephalograph

Public Device Record Key

db405006-e0c9-4a4e-92ad-57183f900256

Public Version Date

February 18, 2019

Public Version Number

1

DI Record Publish Date

January 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-