Defibrillator / Transcutaneous Pacemaker Analyzer - The DELTA 3300 Defibrillator / Transcutaneous - NETECH CORPORATION

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).

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More Product Details

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

Product Characteristics

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 Details

Product Code

DRL

Product Code Name

Tester, Defibrillator

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NETECH CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3