Catalog Number

-

Brand Name

Q-Stress

Version/Model Number

QS-6AA-DDCAA

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

K001492,K082173,K152944

Product Code

DPS

Product Code Name

Electrocardiograph

Public Device Record Key

fd33162a-94f3-46de-9c1a-41b4413bea39

Public Version Date

June 29, 2020

Public Version Number

4

DI Record Publish Date

March 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-