DRL · Tester, Defibrillator
Cardiovascular · 21 CFR 870.5325 · Class 2
Overview
| Product Code | DRL |
|---|---|
| Device Name | Tester, Defibrillator |
| Regulation | 21 CFR 870.5325 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A defibrillator tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load. Some testers also provide waveform information.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K190437 | Delta 3300 | Netech Corporation | Aug 28, 2019 | SESE |
| K182905 | UniPulse | Seaward Group | Dec 14, 2018 | SESE |
| K153210 | Defibrillator Analyzer Variable Load | Bc Group International, Inc. | Dec 21, 2015 | SESE |
| K110192 | DEFIBRILLATOR ANALYZER - DA-2006P | Bc Group International, Inc. | Feb 8, 2011 | SESE |
| K083347 | IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS | Fluke Biomedical | Dec 24, 2008 | SESE |
| K072114 | IMPULSE 6000D/7000DP | Fluke Biomedical | Jan 28, 2008 | SESE |
| K062099 | PHASE 3, MODEL DT-1 | Datrend Systems, Inc. | Jan 25, 2007 | SESE |
| K030547 | MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE | Guardian Angel Products, Inc. | Jul 11, 2003 | SESE |
| K963190 | QA-40M DEFIBRILLATOR TESTER | Metron U.S., Inc. | Jul 1, 1997 | SESE |
| K961595 | DEFIBRILLATOR ANALYZER, DELTA 1000 | Netech Corp. | Oct 29, 1996 | SESE |
| K954391 | MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER | Bio-Tek Instruments, Inc. | Nov 17, 1995 | SESE |
| K941404 | IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER | Hogan & Hartson | Jun 29, 1994 | SESE |
| K934254 | IMPULSE 3000 DEFIBRILLATOR ANALYZER | Dynatech/Nevada, Inc. | Nov 23, 1993 | SESE |
| K904159 | DEFIBRILLATOR ANALYZER MODEL QED-5 | Bio-Tek Instruments, Inc. | Mar 18, 1991 | SESE |
| K896985 | ZAP-GUARD | Guardian Angel Products, Inc. | Jul 31, 1990 | SESE |
| K895525 | MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER | Matrix Medica, Inc. | Jan 26, 1990 | SESE |
| K880780 | HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG | First Medical Devices Corp. | May 12, 1988 | SESE |
| K790394 | DEFIBRILLATOR INTERAL PADDLE TEST LOAD | Physio-Control Corp. | Mar 23, 1979 | SESE |
| K782033 | CARDIAC CARE Q/C TEST KIT | Instrumentation Laboratory CO | Dec 15, 1978 | SESE |
Top Applicants
- Bc Group International, Inc. — 2 clearances
- Bio-Tek Instruments, Inc. — 2 clearances
- Fluke Biomedical — 2 clearances
- Guardian Angel Products, Inc. — 2 clearances
- Datrend Systems, Inc. — 1 clearance
