Catalog Number

-

Brand Name

DL800 Biomedical SYS

Version/Model Number

900-0543-19

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

Yes

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

-

FDA Premarket Submission

K993618

Product Code

MWJ

Product Code Name

Electrocardiograph,Ambulatory(Without Analysis)

Public Device Record Key

d17ab1ab-6eb6-4320-b37b-9ccb51a48148

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

February 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-