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
73–96 of 166
Cleared Aug 02, 1988
CARDIOLIFE TEC-7300 W/OPTIONAL ACCESSORIES
K880575
Nihon Kohden America, Inc.
Cardiovascular · 174d
Cleared Aug 02, 1988
MODEL #825 ADULT STIM. PADS POLYMER TYPE
K882337
Cardiotronics, Inc.
Cardiovascular · 57d
Cleared Jul 27, 1988
LIFEPAK 9 DEFIBRILLATOR AND CARDIAC MONITOR
K881153
Physio-Control Corp.
Cardiovascular · 132d
Cleared Jan 28, 1988
450SLL DEFIBRILLATOR
K874204
Medical Research Laboratories, Inc.
Cardiovascular · 105d
Cleared May 20, 1987
FAST-PATCH(TM)
K871224
Physio-Control Corp.
Cardiovascular · 54d
Cleared Nov 12, 1986
K-STIK DEFIBRILLATION PADS
K863899
Katecho, Inc.
Cardiovascular · 36d
Cleared Oct 31, 1986
CARDIOLIFE TEC 7100
K863404
Nihon Kohden America, Inc.
Cardiovascular · 58d
Cleared Oct 31, 1986
CARDIOLIFE TEC 7200
K863405
Nihon Kohden America, Inc.
Cardiovascular · 58d
Cleared Sep 05, 1986
MODEL 617D
K863303
Quinton, Inc.
Cardiovascular · 11d
Cleared Mar 31, 1986
DEFIB-PADS
K855082
Conmedcorp
Cardiovascular · 102d
Cleared Dec 04, 1985
KONTRON DEFIBRILLATOR 7501
K854307
Kontron Instruments, Inc.
Cardiovascular · 40d
Cleared Oct 11, 1985
MODEL 43130A DEFIBRILLATOR
K853439
Hewlett-Packard Co.
Cardiovascular · 56d
Cleared Aug 29, 1985
DEFI 502
K851485
Robert Bosch Corp.
Cardiovascular · 136d
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 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
EXTERNAL PEDIATRIC DEFIBRILLATOR PADDLE
K842667
Marquette Electronics, Inc.
Cardiovascular · 48d
Cleared Jun 11, 1984
PORTA PAK 90
K840900
Medical Research Laboratories, Inc.
Cardiovascular · 104d