Defibrillator Analyzer, Delta 1000
FDA 510(k)Class II (US FDA 510(k))
by Netech Corp.
Identifiers
- 510(k) Number
- K961595 FDA 510(k)
- FDA Product Code
- DRL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5325 FDA 510(k)
- Regulation Number
- 870.5325 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Defibrillator Analyzer, Delta 1000 is a Tester, Defibrillator device classified under product code DRL and regulation number 870.5325. It is designed to test and analyze defibrillator performance, ensuring proper function of life-support equipment.
This device is supplied as a reusable analyzer for use in clinical or biomedical settings. It received FDA 510(k) clearance (K961595) on October 29, 1996, as a substantially equivalent device under traditional review. No information regarding sterility, single-use status, MRI safety, sizes, or storage conditions is provided in the data.
Frequently asked questions
What is the Defibrillator Analyzer, Delta 1000 used for?
The Defibrillator Analyzer, Delta 1000 is designed to test and analyze defibrillator performance, ensuring proper function of life-support equipment in clinical or biomedical environments.
Is the Defibrillator Analyzer, Delta 1000 reusable or single-use?
The device is supplied as a reusable analyzer, meaning it can be used multiple times after appropriate cleaning and maintenance, as indicated in the device description.
What regulatory pathway was used for the Defibrillator Analyzer, Delta 1000?
The Defibrillator Analyzer, Delta 1000 received FDA 510(k) clearance (K961595) on October 29, 1996, as a substantially equivalent device under a traditional review process.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K961595 FDA 510 (k) - DEFIBRILLATOR ANALYZER | Netech Corp., Defibrillator Testing | AED Analyzer & Defib Tester Equipment, DEFIBRILLATOR ANALYZER, DELTA 1000 (K961595) — FDA 510 (k) | Innolitics, Defibrillator Analyzer - Delta 3300 - Netech
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K961595 | Class II | Active |
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Manufacturer
- Manufacturer
- Netech Corp.
Sources (1)
- FDA 510(k) K961595 24 fields · synced Sep 22, 2026