Catalog Number

9PMS3060

Brand Name

CardioMD

Version/Model Number

CardioMD Gamma Camera System

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 04, 2018

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K011611

Product Code

KPS

Product Code Name

System, Tomography, Computed, Emission

Public Device Record Key

572aa905-2348-449b-a159-1cf096d22e53

Public Version Date

August 22, 2019

Public Version Number

5

DI Record Publish Date

February 09, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-