Catalog Number

SW000466

Brand Name

Ascom

Version/Model Number

Cardiomax

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K103634

Product Code

MSX

Product Code Name

System,Network And Communication,Physiological Monitors

Public Device Record Key

2f3d1a1d-dda1-451a-b91c-e499db3d4049

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 16, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-