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
25–48 of 166
Cleared May 20, 1997
ZOLL AUTOCLAVABLE INTERNAL HANDLES
K963781
Zoll Medical Corp
Cardiovascular · 242d
Cleared Dec 11, 1996
700-F SERIES STIMULATION ELECTRODES
K964469
Cardiotronics Systems, Inc.
Cardiovascular · 34d
Cleared Nov 19, 1996
CARDIOSERV S
K962551
Marquette Electronics, Inc.
Cardiovascular · 144d
Cleared Sep 15, 1995
CARDIO SERV
K951110
Hellige GmbH
Cardiovascular · 189d
Cleared Jun 05, 1995
DPD DEFIBRILLATOR
K952085
Medical Research Laboratories, Inc.
Cardiovascular · 33d
Cleared Sep 07, 1994
UNIPOWER RECHARGEABLE BATTERY PACK
K940842
Unipower Corp.
Cardiovascular · 196d
Cleared Jul 26, 1994
NCE REPLACEMENT BATTERIES
K941995
National Custom Ent., Inc.
Cardiovascular · 92d
Cleared Jul 25, 1994
PEDIATRIC DEFIB K-PADS
K935083
Katecho, Inc.
Cardiovascular · 273d
Cleared Mar 28, 1994
UNIPOWERR RECHARGEABLE BATTERY PACK
K935111
Unipower Corp.
Cardiovascular · 154d
Cleared Mar 16, 1994
VITAL-COMBO(R)
K922315
Physio-Control Corp.
Cardiovascular · 667d
Cleared Feb 17, 1994
RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB
K934015
Portable Power Systems, Inc.
Cardiovascular · 184d
Cleared Feb 17, 1994
BATTERY PACK# S1024NC
K934508
Portable Power Systems, Inc.
Cardiovascular · 156d
Cleared Feb 03, 1994
BATTERY PACK #1012NC
K931266
Portable Power Systems, Inc.
Cardiovascular · 332d
Cleared Dec 16, 1993
LIFEPAK 9 DEFIBRILLATOR/MONITOR
K935674
Physio-Control Corp.
Cardiovascular · 8d
Cleared Oct 15, 1993
ZOLL PD 5300
K931787
Zoll Medical Corp
Cardiovascular · 186d
Cleared Oct 08, 1993
5200 ADULT SOLID GEL MULTI-FUNCTION ELECTRODES
K931803
Zoll Medical Corp
Cardiovascular · 179d
Cleared Oct 08, 1993
ZOLL D 5400 ADULT SOLID GEL DEFIBRILLATION ELECTRO
K931804
Zoll Medical Corp
Cardiovascular · 179d
Cleared Oct 08, 1993
ZOLL PD 5200C ADULT SOLID GEL MULTI-FUNCTION ELECT
K931805
Zoll Medical Corp
Cardiovascular · 179d
Cleared Sep 23, 1993
CARDIAC THERAPHY SYSTEM SCP 900
K921666
Ppg Hellige B.V.
Cardiovascular · 534d
Cleared Jun 25, 1993
DPD DEFIBRILLATOR
K930548
Medical Research Laboratories, Inc.
Cardiovascular · 142d
Cleared May 18, 1993
LIFEPAK 10 DEFIBRILLATOR/MONITOR W/OPT PACEMAKER
K931053
Physio-Control Corp.
Cardiovascular · 71d
Cleared Mar 03, 1993
PRIMEDIC DEFIBRILLATORS-N/B
K921765
Metronic Electronic GmbH
Cardiovascular · 323d
Cleared Dec 29, 1992
MARQUETTE SERIES 360 DEFIBRILLATOR
K921487
Marquette Electronics, Inc.
Cardiovascular · 274d
Cleared Oct 05, 1992
BATTERY PACK
K923864
Portable Power Systems, Inc.
Cardiovascular · 63d