Product code DRL
- Device name
- Tester, Defibrillator
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.5325
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K190437 | Delta 3300 | Netech Corporation | 2019-08-28 |
| K182905 | UniPulse | Seaward Group | 2018-12-14 |
| K153210 | Defibrillator Analyzer Variable Load | Bc Group International, Inc. | 2015-12-21 |
| K110192 | DEFIBRILLATOR ANALYZER - DA-2006P | Bc Group International, Inc. | 2011-02-08 |
| K083347 | IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS | Fluke Biomedical | 2008-12-24 |
| K072114 | IMPULSE 6000D/7000DP | Fluke Biomedical | 2008-01-28 |
| K062099 | PHASE 3, MODEL DT-1 | Datrend Systems, Inc. | 2007-01-25 |
| K030547 | MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE | Guardian Angel Products, Inc. | 2003-07-11 |
| K963190 | QA-40M DEFIBRILLATOR TESTER | Metron U.S., Inc. | 1997-07-01 |
| K961595 | DEFIBRILLATOR ANALYZER, DELTA 1000 | Netech Corp. | 1996-10-29 |
| K954391 | MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER | Bio-Tek Instruments, Inc. | 1995-11-17 |
| K941404 | IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER | Hogan & Hartson | 1994-06-29 |
| K934254 | IMPULSE 3000 DEFIBRILLATOR ANALYZER | Dynatech/Nevada, Inc. | 1993-11-23 |
| K904159 | DEFIBRILLATOR ANALYZER MODEL QED-5 | Bio-Tek Instruments, Inc. | 1991-03-18 |
| K896985 | ZAP-GUARD | Guardian Angel Products, Inc. | 1990-07-31 |
| K895525 | MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER | Matrix Medica, Inc. | 1990-01-26 |
| K880780 | HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG | First Medical Devices Corp. | 1988-05-12 |
| K790394 | DEFIBRILLATOR INTERAL PADDLE TEST LOAD | Physio-Control Corp. | 1979-03-23 |
| K782033 | CARDIAC CARE Q/C TEST KIT | Instrumentation Laboratory CO | 1978-12-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B3356600 | Defibrillator / Transcutaneous Pacemaker Analyzer | NETECH CORPORATION | 2020-03-05 |
| 00850540007119 | Impulse 6000D | FLUKE ELECTRONICS CORPORATION | 2018-05-24 |
| 00850540007126 | Impulse 7000DP | FLUKE ELECTRONICS CORPORATION | 2018-05-24 |
| 00850540007133 | Impulse 4000 | FLUKE ELECTRONICS CORPORATION | 2018-05-24 |
| 00850540007140 | Impulse 7010 | FLUKE ELECTRONICS CORPORATION | 2018-05-24 |
| B418PHASE380004400 | Datrend | Datrend Systems Inc | 2017-08-18 |
| B3356500 | Defibrillator Analyzer | NETECH CORPORATION | 2017-06-16 |
| B223011403 | ZAP GUARD | GUARDIAN ANGEL PRODUCTS INC | 2017-03-14 |
| B22391766 | ZAP GUARD | GUARDIAN ANGEL PRODUCTS INC | 2017-03-14 |
| 00863313000309 | BC Biomedical Defibrillator Analyzer | BC GROUP INTERNATIONAL, INC. | 2016-09-24 |
| 00863313000316 | BC Biomedical Defibrillator Analyzer | BC GROUP INTERNATIONAL, INC. | 2016-09-24 |
| 00863313000323 | BC Biomedical Defibrillator Analyzer Variable Load | BC GROUP INTERNATIONAL, INC. | 2016-09-24 |
| 00863313000330 | Gossen Metrawatt SECULIFE | BC GROUP INTERNATIONAL, INC. | 2016-09-24 |
| 00863313000347 | Gossen Metrawatt SECULIFE | BC GROUP INTERNATIONAL, INC. | 2016-09-24 |
| 00863313000354 | Gossen Metrawatt SECULIFE | BC GROUP INTERNATIONAL, INC. | 2016-09-24 |