Impulse 3000 Defibrillator Analyzer
FDA 510(k) K934254 · Dynatech/Nevada, Inc.
510(k) numberK934254
Submission
- Device name
- Impulse 3000 Defibrillator Analyzer
- Applicant
- Dynatech/Nevada, Inc.
Washington, DC, US - Received
- August 31, 1993
- Decision date
- November 23, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRL – Tester, Defibrillator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5325
- Specialty
- Cardiovascular
Other 510(k)s with product code DRL
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|---|---|---|---|
| K190437 | Delta 3300DRL · Traditional | Netech Corporation | 08/28/2019SE |
| K182905 | UniPulseDRL · Traditional | Seaward Group | 12/14/2018SE |
| K153210 | Defibrillator Analyzer Variable LoadDRL · Traditional | Bc Group International, Inc. | 12/21/2015SE |
| K110192 | Defibrillator Analyzer - DA-2006PDRL · Traditional | Bc Group International, Inc. | 02/08/2011SE |
| K083347 | Impulse 7010 Defibrillator Selectable LoadsDRL · Traditional | Fluke Biomedical | 12/24/2008SE |
| K072114 | Impulse 6000D/7000DPDRL · Traditional | Fluke Biomedical | 01/28/2008SE |
| K062099 | Phase 3, Model DT-1DRL · Traditional | Datrend Systems, Inc. | 01/25/2007SE |
| K030547 | Modification to Zap Guard Defibrillator Test ProbeDRL · Special | Guardian Angel Products, Inc. | 07/11/2003SE |
| K963190 | QA-40M Defibrillator TesterDRL · Traditional | Metron U.S., Inc. | 07/01/1997SE |
| K961595 | Defibrillator Analyzer, Delta 1000DRL · Traditional | Netech Corp. | 10/29/1996SE |
More from Netech Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K942546 | Cufflink Non-Invasive Blood Pressure AnalyzerDXN · Traditional | 01/27/1995SE |
| K935817 | Medsim 300 Patient SimulatorDRT · Traditional | 01/18/1994SE |
| K897074 | Model 215M Patient SimulatorDSI · Traditional | 05/17/1990SE |
| K897029 | Model ECG100 SimulatorDPS · Traditional | 04/26/1990SE |
| K897096 | Model 404A I.V. Infusion Pump AnalyzerFRN · Traditional | 03/15/1990SE |
Questions and answers
When was Impulse 3000 Defibrillator Analyzer cleared by the FDA?
Impulse 3000 Defibrillator Analyzer (K934254) received a 510(k) decision of Substantially Equivalent on November 23, 1993, 84 days after the submission was received.
What is the product code of K934254?
The FDA product code is DRL – Tester, Defibrillator, a Class II (moderate risk) device regulated under 21 CFR 870.5325.