Catalog Number

10A1087

Brand Name

ZOLL Arrhythmia Management System

Version/Model Number

Sensor

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K190939

Product Code

DSI

Product Code Name

Detector And Alarm, Arrhythmia

Public Device Record Key

7d19235c-59fb-456c-9320-3c4dacbe4410

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

October 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-