Catalog Number

-

Brand Name

FUKUDA DENSHI

Version/Model Number

DS-8900

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

K000746,K020084,K970585,K980728

Product Code

DSI

Product Code Name

Detector And Alarm, Arrhythmia

Public Device Record Key

4213e5a2-8e4d-4460-9828-d778cb05ac1d

Public Version Date

May 19, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-