DRO · Class II · 21 CFR 870.5550

FDA Product Code DRO: Pacemaker, Cardiac, External Transcutaneous (non-invasive)

Leading manufacturers include Cardiac Resucitator Corp., Physio-Control Corp. and Cardiotronics, Inc..

84
Total
84
Cleared
105d
Avg days
1982
Since

FDA 510(k) Cleared Pacemaker, Cardiac, External Transcutaneous (non-invasive) Devices (Product Code DRO)

84 devices
1–24 of 84
Cleared Oct 12, 2001
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
K012404
Katecho, Inc.
Cardiovascular · 74d
Cleared Mar 28, 2000
ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413
K000660
Medical Data Electronics
Cardiovascular · 29d
Cleared Sep 15, 1999
PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
K983196
Tz Medical, Inc.
Cardiovascular · 369d
Cleared Sep 15, 1999
PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT
K983232
Tz Medical, Inc.
Cardiovascular · 366d
Cleared Mar 02, 1998
PORTABLE INTENSIVE CARE UNIT
K974034
Medical Research Laboratories, Inc.
Cardiovascular · 130d
Cleared Mar 06, 1997
CARDIOSERV P
K962547
Marquette Electronics, Inc.
Cardiovascular · 251d
Cleared Feb 28, 1997
RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM
K963120
Marquette Electronics, Inc.
Cardiovascular · 200d
Cleared Dec 10, 1996
ESORT II + 400 SERIES MONITOR
K961138
Medical Data Electronics
Cardiovascular · 264d
Cleared Dec 29, 1995
ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000
K950856
Zoll Medical Corp
Cardiovascular · 305d
Cleared Dec 29, 1995
LIFEPAK 11
K951593
Physio-Control Corp.
Cardiovascular · 267d
Cleared May 22, 1995
HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR
K950483
Hewlett-Packard Co.
Cardiovascular · 108d
Cleared Apr 15, 1993
K-DEFIB/PACE CARBON ELECTRODE
K926175
Katecho, Inc.
Cardiovascular · 128d
Cleared Jul 30, 1992
MODELS M1722A, M1723A, M1724A DEFIBRILLATORS
K915757
Hewlett-Packard Co.
Cardiovascular · 220d
Cleared Jun 29, 1992
GEL-TAC
K915328
Katecho, Inc.
Cardiovascular · 216d
Cleared May 14, 1992
K-DEFIB/PACE ELECTRODE
K914955
Katecho, Inc.
Cardiovascular · 191d
Cleared Sep 11, 1991
QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC
K912599
Physio-Control Corp.
Cardiovascular · 93d
Cleared May 02, 1991
MODEL 205 SHOCK-TRODE
K910661
Cardiotronics, Inc.
Cardiovascular · 78d
Cleared Dec 20, 1989
NKA MODEL SEC-3102 CARDIAC STIMULATOR
K894492
Nihon Kohden America, Inc.
Cardiovascular · 155d
Cleared Oct 26, 1989
DEFIB/PACING PADS
K894588
Conmedcorp
Cardiovascular · 94d
Cleared Jan 12, 1989
MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE
K885171
Andover Medical, Inc.
Cardiovascular · 30d
Cleared Dec 16, 1988
MRL PACETTE, 450SLL
K880932
Medical Research Laboratories, Inc.
Cardiovascular · 284d
Cleared Nov 18, 1988
TRIAD-EP II, PUSHBUTTON, CABLE INPUT
K884532
Cardiotronics, Inc.
Cardiovascular · 21d
Cleared Nov 17, 1988
TRIAD-EP II, PLATE INPUT
K884530
Cardiotronics, Inc.
Cardiovascular · 20d
Cleared Nov 09, 1988
TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE
K883178
Cardiotronics, Inc.
Cardiovascular · 105d

About Product Code DRO - Regulatory Context