DRL · Class II · 21 CFR 870.5325

FDA Product Code DRL: Tester, Defibrillator

Leading manufacturers include Fluke Biomedical, Bc Group International, Inc. and Bio-Tek Instruments, Inc..

19
Total
19
Cleared
119d
Avg days
1978
Since

FDA 510(k) Cleared Tester, Defibrillator Devices (Product Code DRL)

19 devices
1–19 of 19
Cleared Aug 28, 2019
Delta 3300
K190437
Netech Corporation
Cardiovascular · 187d
Cleared Dec 14, 2018
UniPulse
K182905
Seaward Group
Cardiovascular · 59d
Cleared Dec 21, 2015
Defibrillator Analyzer Variable Load
K153210
Bc Group International, Inc.
Cardiovascular · 46d
Cleared Feb 08, 2011
DEFIBRILLATOR ANALYZER - DA-2006P
K110192
Bc Group International, Inc.
Cardiovascular · 15d
Cleared Dec 24, 2008
IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS
K083347
Fluke Biomedical
Cardiovascular · 41d
Cleared Jan 28, 2008
IMPULSE 6000D/7000DP
K072114
Fluke Biomedical
Cardiovascular · 180d
Cleared Jan 25, 2007
PHASE 3, MODEL DT-1
K062099
Datrend Systems, Inc.
Cardiovascular · 185d
Cleared Jul 01, 1997
QA-40M DEFIBRILLATOR TESTER
K963190
Metron U.S., Inc.
Cardiovascular · 320d
Cleared Oct 29, 1996
DEFIBRILLATOR ANALYZER, DELTA 1000
K961595
Netech Corp.
Cardiovascular · 188d
Cleared Nov 17, 1995
MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER
K954391
Bio-Tek Instruments, Inc.
Cardiovascular · 59d
Cleared Jun 29, 1994
IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER
K941404
Hogan & Hartson
Cardiovascular · 98d
Cleared Mar 18, 1991
DEFIBRILLATOR ANALYZER MODEL QED-5
K904159
Bio-Tek Instruments, Inc.
Cardiovascular · 188d
Cleared Mar 23, 1979
DEFIBRILLATOR INTERAL PADDLE TEST LOAD
K790394
Physio-Control Corp.
Cardiovascular · 25d
Cleared Dec 15, 1978
CARDIAC CARE Q/C TEST KIT
K782033
Instrumentation Laboratory CO
Cardiovascular · 9d

About Product Code DRL - Regulatory Context