LDD · Class II · 21 CFR 870.5300

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

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

166
Total
166
Cleared
120d
Avg days
1978
Since
166 devices
25–48 of 166
Cleared Jul 18, 1990
THREADED PADDLE PAIRS, INTERNAL ADULT PEDI INFANT
K902590
Marquette Electronics, Inc.
Cardiovascular · 36d
Cleared Feb 26, 1990
LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)
K895379
Physio-Control Corp.
Cardiovascular · 180d
Cleared Dec 12, 1989
MARQUETTE 1200 DEFIBRILLATION PADS
K895651
Marquette Electronics, Inc.
Cardiovascular · 83d
Cleared Aug 03, 1989
MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE
K893403
Hewlett-Packard Co.
Cardiovascular · 94d
Cleared Feb 23, 1989
LIFEPAK 10 DEFIBRILLATOR/MONITOR
K890079
Physio-Control Corp.
Cardiovascular · 50d
Cleared Dec 28, 1988
LIFEPAK 50 MONITOR/DEFIBRILLATOR
K883617
Physio-Control Corp.
Cardiovascular · 126d
Cleared Aug 02, 1988
CARDIOLIFE TEC-7300 W/OPTIONAL ACCESSORIES
K880575
Nihon Kohden America, Inc.
Cardiovascular · 174d
Cleared Jul 27, 1988
LIFEPAK 9 DEFIBRILLATOR AND CARDIAC MONITOR
K881153
Physio-Control Corp.
Cardiovascular · 132d
Cleared May 20, 1987
FAST-PATCH(TM)
K871224
Physio-Control Corp.
Cardiovascular · 54d
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 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 14, 1985
M/D4 W/CHARGER (CARDIOPAC 3M11)
K844447
Datascope Corp.
Cardiovascular · 59d
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 May 23, 1984
TEC-3500 DEFIBRILLATOR
K840258
Nihon Kohden America, Inc.
Cardiovascular · 121d