Tester, Defibrillator
FDA product code DRL · Class II (moderate risk) · 21 CFR 870.5325 · Cardiovascular
19510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Guardian Angel Products, Inc. 2
- Bio-Tek Instruments, Inc. 2
- Netech Corp. 2
- Fluke Biomedical 2
- Bc Group International, Inc. 2
- Instrumentation Laboratory CO 1
- Physio-Control Corp. 1
- First Medical Devices Corp. 1
- Matrix Medica, Inc. 1
- Dynatech/Nevada, Inc. 1
- Hogan & Hartson 1
- Metron U.S., Inc. 1
- Datrend Systems, Inc. 1
- Seaward Group 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K954391 | Models QED-6, 6M and 6H Defibrillator Analyzer with Optional Universal Pacemaker Load…DRL · Traditional | Bio-Tek Instruments, Inc. | 11/17/1995SE |
| K941404 | Impulse 4000 Defibrillator/Transcutaneous Pacer AnalyzerDRL · Traditional | Hogan & Hartson | 06/29/1994SE |
| K934254 | Impulse 3000 Defibrillator AnalyzerDRL · Traditional | Dynatech/Nevada, Inc. | 11/23/1993SE |
| K904159 | Defibrillator Analyzer Model QED-5DRL · Traditional | Bio-Tek Instruments, Inc. | 03/18/1991SE |
| K896985 | Zap-GuardDRL · Traditional | Guardian Angel Products, Inc. | 07/31/1990SE |
| K895525 | Matrx Battery Charger/Defibrillator TesterDRL · Traditional | Matrix Medica, Inc. | 01/26/1990SE |
| K880780 | Heartstart 2000 Defibrillator Tester, ECGDRL · Traditional | First Medical Devices Corp. | 05/12/1988SE |
| K790394 | Defibrillator Interal Paddle Test LoadDRL · Traditional | Physio-Control Corp. | 03/23/1979SE |
| K782033 | Cardiac Care Q/C Test KitDRL · Traditional | Instrumentation Laboratory CO | 12/15/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0457-2016 Class III | DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output…Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed… | BC Group International Inc | 10/28/2015Terminated |