Duns Number:177242153
Device Description: The DELTA 3300 Defibrillator / Transcutaneous Pacemaker Analyzer is a precision instrument The DELTA 3300 Defibrillator / Transcutaneous Pacemaker Analyzer is a precision instrument for testing defibrillators and external (Transcutaneous) Pacemakers. It combines the complete testing functions of a Defibrillator Tester, Transcutaneous Pacemaker Analyzer, and 12-Lead ECG / Arrhythmia Simulator into one compact, lightweight, and easy-to-use instrument.The Delta 3300 tests all Defibrillators including AEDs. It measures both monophasic and Bi-Phasic waveforms. It is compact, lightweight and easy to use. The test results can be saved in the internal memory and uploaded to the PC and printed using ProComPrint software (CD included with the unit).
Catalog Number
660
Brand Name
Defibrillator / Transcutaneous Pacemaker Analyzer
Version/Model Number
DELTA 3300
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"
Yes
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
-
Product Code
DRL
Product Code Name
Tester, Defibrillator
Public Device Record Key
8c1daa41-8de1-4f44-ba9d-212f9ae61d52
Public Version Date
March 13, 2020
Public Version Number
1
DI Record Publish Date
March 05, 2020
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 |