FDA Product Code
FDA Product Code DRL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5325
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K190437 | Delta 3300 | Netech Corporation | 2019-08-28 | Traditional | PDF ↗ |
| K182905 | UniPulse | Seaward Group | 2018-12-14 | Traditional | PDF ↗ |
| K153210 | Defibrillator Analyzer Variable Load | Bc Group International, Inc. | 2015-12-21 | Traditional | PDF ↗ |
| K110192 | DEFIBRILLATOR ANALYZER - DA-2006P | Bc Group International, Inc. | 2011-02-08 | Traditional | PDF ↗ |
| K083347 | IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS | Fluke Biomedical | 2008-12-24 | Traditional | PDF ↗ |
| K072114 | IMPULSE 6000D/7000DP | Fluke Biomedical | 2008-01-28 | Traditional | PDF ↗ |
| K062099 | PHASE 3, MODEL DT-1 | Datrend Systems, Inc. | 2007-01-25 | Traditional | PDF ↗ |
| K030547 | MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE | Guardian Angel Products, Inc. | 2003-07-11 | Special | PDF ↗ |
| K963190 | QA-40M DEFIBRILLATOR TESTER | Metron U.S., Inc. | 1997-07-01 | Traditional | PDF ↗ |
| K961595 | DEFIBRILLATOR ANALYZER, DELTA 1000 | Netech Corp. | 1996-10-29 | Traditional | PDF ↗ |
| K954391 | MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER | Bio-Tek Instruments, Inc. | 1995-11-17 | Traditional | PDF ↗ |
| K941404 | IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER | Hogan & Hartson | 1994-06-29 | Traditional | PDF ↗ |
| K934254 | IMPULSE 3000 DEFIBRILLATOR ANALYZER | Dynatech/Nevada, Inc. | 1993-11-23 | Traditional | PDF ↗ |
| K904159 | DEFIBRILLATOR ANALYZER MODEL QED-5 | Bio-Tek Instruments, Inc. | 1991-03-18 | Traditional | PDF ↗ |
| K896985 | ZAP-GUARD | Guardian Angel Products, Inc. | 1990-07-31 | Traditional | PDF ↗ |
| K895525 | MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER | Matrix Medica, Inc. | 1990-01-26 | Traditional | PDF ↗ |
| K880780 | HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG | First Medical Devices Corp. | 1988-05-12 | Traditional | PDF ↗ |
| K790394 | DEFIBRILLATOR INTERAL PADDLE TEST LOAD | Physio-Control Corp. | 1979-03-23 | Traditional | PDF ↗ |
| K782033 | CARDIAC CARE Q/C TEST KIT | Instrumentation Laboratory CO | 1978-12-15 | Traditional | PDF ↗ |
Product code DRL · Class II · Cardiovascular. Data: openFDA.