DRL — Tester, Defibrillator Class II
FDA Device Classification
Classification Details
- Product Code
- DRL
- Device Class
- Class II
- Regulation Number
- 870.5325
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K190437 | netech corporation | Delta 3300 | August 28, 2019 |
| K182905 | seaward group | UniPulse | December 14, 2018 |
| K153210 | bc group international | Defibrillator Analyzer Variable Load | December 21, 2015 |
| K110192 | bc group international | DEFIBRILLATOR ANALYZER - DA-2006P | February 8, 2011 |
| K083347 | fluke biomedical | IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS | December 24, 2008 |
| K072114 | fluke biomedical | IMPULSE 6000D/7000DP | January 28, 2008 |
| K062099 | datrend systems | PHASE 3, MODEL DT-1 | January 25, 2007 |
| K030547 | guardian angel products | MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE | July 11, 2003 |
| K963190 | metron u.s | QA-40M DEFIBRILLATOR TESTER | July 1, 1997 |
| K961595 | netech | DEFIBRILLATOR ANALYZER, DELTA 1000 | October 29, 1996 |
| K954391 | bio-tek instruments | MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER | November 17, 1995 |
| K941404 | hogan and hartson | IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER | June 29, 1994 |
| K934254 | dynatech/nevada | IMPULSE 3000 DEFIBRILLATOR ANALYZER | November 23, 1993 |
| K904159 | bio-tek instruments | DEFIBRILLATOR ANALYZER MODEL QED-5 | March 18, 1991 |
| K896985 | guardian angel products | ZAP-GUARD | July 31, 1990 |
| K895525 | matrix medica | MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER | January 26, 1990 |
| K880780 | first medical devices | HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG | May 12, 1988 |
| K790394 | physio-control | DEFIBRILLATOR INTERAL PADDLE TEST LOAD | March 23, 1979 |
| K782033 | instrumentation laboratory | CARDIAC CARE Q/C TEST KIT | December 15, 1978 |