Catalog Number

NEMK157

Brand Name

DR400

Version/Model Number

DR400

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K142424

Product Code

MWJ

Product Code Name

Electrocardiograph, Ambulatory (Without Analysis)

Public Device Record Key

a3d1c2f2-ec07-4bea-8805-958f8f65792d

Public Version Date

November 04, 2021

Public Version Number

1

DI Record Publish Date

October 27, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-