DRL — Tester, Defibrillator Class II
FDA product code DRL covers "Tester, Defibrillator", a Class II medical device regulated under 21 CFR 870.5325. Submissions are reviewed by the Cardiovascular panel. At least 19 recent 510(k) clearances have been granted under this product code.
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 |