Duns Number:177242153
Device Description: Delta 3000 is a full function defibrillator analyzer including Transcutaneous Pacemakers. Delta 3000 is a full function defibrillator analyzer including Transcutaneous Pacemakers. In addition to the capability of testing all bi-polar defibrillators, it tests all Transcutaneous pacers, Atrial and Ventricular pacemakers. Delta 3000 is compact, light weight and easy to use. Among the functions include energy, peak voltage as well as cardio version, 10 lead ECG Arrhythmia waveform.Test results can be easily uploaded to a PC through the serial port.
Catalog Number
650
Brand Name
Defibrillator Analyzer
Version/Model Number
Delta 3000
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K961595
Product Code
DRL
Product Code Name
Tester, Defibrillator
Public Device Record Key
ee096cc1-dbbc-4436-aedf-16a545e7aefb
Public Version Date
July 20, 2018
Public Version Number
4
DI Record Publish Date
June 16, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |