Catalog Number

-

Brand Name

Millennia Software

Version/Model Number

900-0621-00

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K024323

Product Code

MLO

Product Code Name

Electrocardiograph, Ambulatory, With Analysis Algorithm

Public Device Record Key

6766c3c8-62eb-4a2b-9f5d-02f85ff74a13

Public Version Date

October 21, 2019

Public Version Number

2

DI Record Publish Date

October 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-