LDD · Class II · 21 CFR 870.5300

FDA Product Code LDD: Dc-defibrillator, Low-energy, (including Paddles)

Leading manufacturers include Physio-Control Corp., Cardiotronics, Inc. and Nihon Kohden America, Inc..

166
Total
166
Cleared
120d
Avg days
1978
Since
166 devices
121–144 of 166
Cleared Oct 11, 1985
MEDIC 4
K853354
Kone Instruments, Inc.
Cardiovascular · 60d
Cleared Oct 11, 1985
MODEL 43130A DEFIBRILLATOR
K853439
Hewlett-Packard Co.
Cardiovascular · 56d
Cleared Sep 16, 1985
2006, 2010, 2011, 2012(CARDIAC DC DEFIBRILLATOR)
K852799
Cardiac Recorders, Ltd.
Cardiovascular · 77d
Cleared Sep 16, 1985
CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO)
K852808
Cardiac Recorders, Ltd.
Cardiovascular · 76d
Cleared Aug 29, 1985
DEFI 502
K851485
Robert Bosch Corp.
Cardiovascular · 136d
Cleared Aug 06, 1985
LITEGUARD 9
K851924
Temtech , Ltd.
Cardiovascular · 96d
Cleared Aug 05, 1985
DEFI 2
K851931
S & W Medico Teknik
Cardiovascular · 95d
Cleared Apr 19, 1985
FC-700 DEFIBRILLATOR
K850618
Fukuda Denshi USA, Inc.
Cardiovascular · 63d
Cleared Apr 10, 1985
PORTABLE DEFIBRILLATOR/MONITOR ED 425
K851092
Honeywell, Inc.
Cardiovascular · 22d
Cleared Feb 12, 1985
MODELS 43100A, 43110A & 43120A DEFIBRILLATOR/MONIT
K844740
Hewlett-Packard Co.
Cardiovascular · 69d
Cleared Jan 18, 1985
CARDIOPAC DEFIBRILLATOR 444
K844103
Birtcher Corp.
Cardiovascular · 87d
Cleared Jan 14, 1985
M/D4 W/CHARGER (CARDIOPAC 3M11)
K844447
Datascope Corp.
Cardiovascular · 59d
Cleared Oct 26, 1984
PERSONAL DEFIBRILLATOR
K832833
Physio-Control, Inc.
Cardiovascular · 434d
Cleared Oct 19, 1984
LS-260G MONITOR/RECORDER & DEFIBILLATOR
K843396
Life Science Instrumentation, Inc.
Cardiovascular · 51d
Cleared Oct 18, 1984
LIFEPAK 8
K842624
Physio-Control Corp.
Cardiovascular · 105d
Cleared Oct 18, 1984
LIFEPAK 200
K843229
Physio-Control Corp.
Cardiovascular · 62d
Cleared Aug 27, 1984
SERVOCARD DEFIBRILLATOR SCP-851
K842235
Litton Datamedix
Cardiovascular · 83d
Cleared Aug 27, 1984
SERVOCARD SCP-840
K842312
Litton Datamedix
Cardiovascular · 76d
Cleared Aug 27, 1984
EXTERNAL PEDIATRIC DEFIBRILLATOR PADDLE
K842667
Marquette Electronics, Inc.
Cardiovascular · 48d
Cleared Jun 11, 1984
PORTA PAK 90
K840900
Medical Research Laboratories, Inc.
Cardiovascular · 104d
Cleared May 23, 1984
TEC-3500 DEFIBRILLATOR
K840258
Nihon Kohden America, Inc.
Cardiovascular · 121d
Cleared Apr 17, 1984
MINI-DEFIBRILLATOR 280/4
K840246
Life Science Instrumentation, Inc.
Cardiovascular · 96d
Cleared Feb 04, 1984
PORTABLE DEFIBRILLATOR
K840167
Honeywell, Inc.
Cardiovascular · 19d
Cleared Jan 11, 1984
PORTA PULSE III #D320
K833751
Medical Research Laboratories, Inc.
Cardiovascular · 77d