Panels › Cardiovascular › Product code DRL · Class 2
Tester, Defibrillator
Regulation 870.5325
0510(k)s in 12 months (19 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in DRL
| Company | 510(k)s | Recalls |
|---|---|---|
| Bc Group International, Inc. | 2 | 1 |
| Bio-Tek Instruments, Inc. | 2 | 0 |
| Fluke Biomedical | 2 | 0 |
| Guardian Angel Products, Inc. | 2 | 0 |
| Netech Corp. | 2 | 0 |
| Datrend Systems, Inc. | 1 | 0 |
| Dynatech/Nevada, Inc. | 1 | 0 |
| First Medical Devices Corp. | 1 | 0 |
| Hogan & Hartson | 1 | 0 |
| Instrumentation Laboratory CO | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 28, 2019 | K190437 | Delta 3300 Netech Corporation | DRL |
| Dec 14, 2018 | K182905 | UniPulse Seaward Group, GB | DRL |
| Dec 21, 2015 | K153210 | Defibrillator Analyzer Variable Load Bc Group International, Inc. | DRL |
| Feb 8, 2011 | K110192 | DEFIBRILLATOR ANALYZER - DA-2006P Bc Group International, Inc. | DRL |
| Dec 24, 2008 | K083347 | IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS Fluke Biomedical | DRL |
| Jan 28, 2008 | K072114 | IMPULSE 6000D/7000DP Fluke Biomedical | DRL |
| Jan 25, 2007 | K062099 | PHASE 3, MODEL DT-1 Datrend Systems, Inc., CA | DRL |
| Jul 11, 2003 | K030547 | MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE Guardian Angel Products, Inc. | DRL |
| Jul 1, 1997 | K963190 | QA-40M DEFIBRILLATOR TESTER Metron U.S., Inc. | DRL |
| Oct 29, 1996 | K961595 | DEFIBRILLATOR ANALYZER, DELTA 1000 Netech Corp. | DRL |
| Nov 17, 1995 | K954391 | MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER Bio-Tek Instruments, Inc. | DRL |
| Jun 29, 1994 | K941404 | IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER Hogan & Hartson | DRL |
| Nov 23, 1993 | K934254 | IMPULSE 3000 DEFIBRILLATOR ANALYZER Dynatech/Nevada, Inc. | DRL |
| Mar 18, 1991 | K904159 | DEFIBRILLATOR ANALYZER MODEL QED-5 Bio-Tek Instruments, Inc. | DRL |
| Jul 31, 1990 | K896985 | ZAP-GUARD Guardian Angel Products, Inc. | DRL |
| Jan 26, 1990 | K895525 | MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER Matrix Medica, Inc. | DRL |
| May 12, 1988 | K880780 | HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG First Medical Devices Corp. | DRL |
| Mar 23, 1979 | K790394 | DEFIBRILLATOR INTERAL PADDLE TEST LOAD Physio-Control Corp. | DRL |
| Dec 15, 1978 | K782033 | CARDIAC CARE Q/C TEST KIT Instrumentation Laboratory CO | DRL |
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