Identity
- Trade Name
- Defibrillator Analyzer FDA UDI
- Generic Name
- External defibrillator tester FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Delta 3000 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 650 FDA UDI
- Primary DI / UDI-DI
- B3356500 FDA UDI
- 510(k) Number
- K961595 FDA UDI
- FDA Product Code
- DRL FDA UDI
- GMDN Term
- External defibrillator tester FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5325 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: External defibrillator tester
Defibrillator Analyzer by Netech Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Netech Corp.
Sources (1)
- FDA UDI ee096cc1-dbbc-4436-aedf-16a545e7aefb 35 fields · synced Jun 8, 2026