Catalog Number

561121

Brand Name

Nox A1s Recorder

Version/Model Number

NOX-APSG1SUS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

8377e5a7-27bf-437e-8b03-4c2490da58bb

Public Version Date

July 19, 2021

Public Version Number

1

DI Record Publish Date

July 10, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-