FDA 510(k) Applications for Medical Device Product Code "DRL"
(Tester, Defibrillator)

FDA 510(k) Number Applicant Device Name Decision Date
K110192 BC GROUP INTERNATIONAL, INC DEFIBRILLATOR ANALYZER - DA-2006P 02/08/2011
K153210 BC GROUP INTERNATIONAL, INC Defibrillator Analyzer Variable Load 12/21/2015
K904159 BIO-TEK INSTRUMENTS, INC. DEFIBRILLATOR ANALYZER MODEL QED-5 03/18/1991
K954391 BIO-TEK INSTRUMENTS, INC. MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER 11/17/1995
K062099 DATREND SYSTEMS, INC. PHASE 3, MODEL DT-1 01/25/2007
K934254 DYNATECH/NEVADA, INC. IMPULSE 3000 DEFIBRILLATOR ANALYZER 11/23/1993
K880780 FIRST MEDICAL DEVICES CORP. HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG 05/12/1988
K072114 FLUKE BIOMEDICAL IMPULSE 6000D/7000DP 01/28/2008
K083347 FLUKE BIOMEDICAL IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS 12/24/2008
K030547 GUARDIAN ANGEL PRODUCTS, INC. MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE 07/11/2003
K896985 GUARDIAN ANGEL PRODUCTS, INC. ZAP-GUARD 07/31/1990
K941404 HOGAN & HARTSON IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER 06/29/1994
K782033 INSTRUMENTATION LABORATORY CO. CARDIAC CARE Q/C TEST KIT 12/15/1978
K895525 MATRIX MEDICA, INC. MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER 01/26/1990
K963190 METRON U.S., INC. QA-40M DEFIBRILLATOR TESTER 07/01/1997
K961595 NETECH CORP. DEFIBRILLATOR ANALYZER, DELTA 1000 10/29/1996
K790394 PHYSIO-CONTROL CORP. DEFIBRILLATOR INTERAL PADDLE TEST LOAD 03/23/1979


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