Catalog Number

-

Brand Name

ADVANCED ELECTROCARDIOGRAPH

Version/Model Number

ECG-12 C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 15, 2028

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

K111805

Product Code

DPS

Product Code Name

Electrocardiograph

Public Device Record Key

b129b0b3-a4b1-48fe-8988-41847a195c07

Public Version Date

March 10, 2021

Public Version Number

2

DI Record Publish Date

April 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-