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
97–120 of 166
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
Cleared Nov 03, 1983
PORTABLE DEFIBRILLATOR MONITOR 74DRK
K831696
Honeywell, Inc.
Cardiovascular · 162d
Cleared Apr 28, 1983
VPD540 DEFIBRILLATOR
K822617
Life Science Instrumentation, Inc.
Cardiovascular · 241d
Cleared Apr 28, 1983
DEFIBRILLATOR VPD 545
K831056
Life Science Instrumentation, Inc.
Cardiovascular · 27d
Cleared Mar 17, 1983
THERACARD 400
K823828
Siemens Medical Solutions USA, Inc.
Cardiovascular · 87d
Cleared Jan 26, 1983
MODEL 78670A
K823268
Hewlett-Packard Co.
Cardiovascular · 85d
Cleared Nov 01, 1982
PORTA FIB III
K822961
Narco Scientific
Cardiovascular · 27d
Cleared Aug 31, 1982
VPD-261 DEFIBRILLATOR MONITOR
K822294
Life Science Instrumentation, Inc.
Cardiovascular · 29d
Cleared Dec 29, 1981
LINE POWERED LOW ENERGY DEFIBRILLATOR II
K813471
Narco Scientific
Cardiovascular · 15d
Cleared Sep 25, 1981
2000 SERIES PORTABLE RESUSCITATION SYST.
K812519
Life Science Instrumentation, Inc.
Cardiovascular · 23d
Cleared Sep 25, 1981
280/4 MINI-DEFIBRILLATOR
K812520
Life Science Instrumentation, Inc.
Cardiovascular · 23d
Cleared Sep 21, 1981
DEFIBRILLATOR/MONITOR
K812317
Hewlett-Packard Co.
Cardiovascular · 35d
Cleared Jul 10, 1981
DATASCOPE INTERNAL DEFIBRILLATOR PADDLES
K811638
Datascope Corp.
Cardiovascular · 30d
Cleared Feb 19, 1981
PORTABLE, BATTERY OPERATED DEFIBRILLATOR
K810237
Honeywell, Inc.
Cardiovascular · 22d
Cleared Dec 12, 1978
DEFIBRILLATOR, MARK II
K781678
Ipco Corp.
Cardiovascular · 71d
Cleared Apr 21, 1978
PANTRIDGE MK III DEFIBRILLATOR/MONITOR
K780416
Ipco Corp.
Cardiovascular · 38d