Catalog Number

395-0009-00

Brand Name

Athena GTX Device Management Suite (ADMS) Software

Version/Model Number

ADMS iOS Software

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K173203

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

274aaf06-9ca2-473f-b839-6a69b134f6bb

Public Version Date

May 19, 2020

Public Version Number

3

DI Record Publish Date

April 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-