Catalog Number

539012

Brand Name

Noxturnal PSG CD

Version/Model Number

NOX-NOXTPSG_CD

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

K192469

Product Code

KZM

Product Code Name

Device, Muscle Monitoring

Public Device Record Key

6d8d8f9e-b929-4abe-82b6-c5f1c78425f2

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

February 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-