FDA 510(k) Applications for Medical Device Product Code "DRO"
(Pacemaker, Cardiac, External Transcutaneous (Non-Invasive))

FDA 510(k) Number Applicant Device Name Decision Date
K854924 A.M.I. CORP. AMI E-Z-PACE ELECTODE 02/26/1986
K860283 ANDOVER MEDICAL, INC. AMI CARDIO-PAD 03/31/1986
K885171 ANDOVER MEDICAL, INC. MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE 01/12/1989
K854853 ASSOCIATED MEDICAL DEVICES, INC. NI-PACER 1 02/14/1986
K860551 BIOTRONICS CORP. ETP 180 CARDIAC PACEMAKER (EXTERNAL) 04/30/1986
K820609 CARDIAC RESUCITATOR CORP. HEART *AID, #80 08/06/1982
K821152 CARDIAC RESUCITATOR CORP. HEART AID #90 08/06/1982
K850170 CARDIAC RESUCITATOR CORP. HEART AID MODEL 97 02/14/1985
K821673 CARDIAC RESUCITATOR CORP. HEART*AID, ALS, MODEL 95 08/06/1982
K843358 CARDIAC RESUCITATOR CORP. HEART-AID MODEL 80 11/19/1984
K871569 CARDIAC RESUCITATOR CORP. MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR 06/08/1987
K871971 CARDIAC RESUCITATOR CORP. MODIFIED PACE*AID MODEL 53 06/24/1987
K813553 CARDIAC RESUCITATOR CORP. PACE *AID 01/18/1982
K843547 CARDIAC RESUCITATOR CORP. PACE *AID MODEL 52 12/17/1984
K844811 CARDIAC RESUCITATOR CORP. PACE AID MODEL 53 01/24/1985
K820507 CARDIAC RESUCITATOR CORP. PACE* AID MODEL 50 08/06/1982
K850596 CARDIAC RESUCITATOR CORP. PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY & 03/06/1985
K871538 CARDIAC RESUCITATOR CORP. STAT-PAD (TM) 06/24/1987
K854233 CARDIO MANAGEMENT, INC. CMI 3000 01/08/1986
K882338 CARDIOTRONICS, INC. MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE 08/30/1988
K883375 CARDIOTRONICS, INC. MODEL #918 MULTI-PADS 08/30/1988
K910661 CARDIOTRONICS, INC. MODEL 205 SHOCK-TRODE 05/02/1991
K883304 CARDIOTRONICS, INC. TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY 11/09/1988
K880936 CARDIOTRONICS, INC. TRIAD-EP 07/18/1988
K884530 CARDIOTRONICS, INC. TRIAD-EP II, PLATE INPUT 11/17/1988
K884532 CARDIOTRONICS, INC. TRIAD-EP II, PUSHBUTTON, CABLE INPUT 11/18/1988
K883178 CARDIOTRONICS, INC. TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE 11/09/1988
K883523 CARDIOTRONICS, INC. TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE 10/06/1988
K894588 CONMED CORP. DEFIB/PACING PADS 10/26/1989
K872368 CONMED CORP. MODIFIED VERSA STIM ELECTRODE LINE 09/18/1987
K895728 DAROX CORP. R2 PACE ADAPTOR CABLE, MODEL 196 10/12/1989
K895729 DAROX CORP. R2 PACE PAD, MODEL 480 10/12/1989
K854196 DIGITAL CARDIOVASCULAR INSTRUMENTS, INC. DCI MODEL EP-2 CLINICAL STIMULATOR 05/01/1986
K950483 HEWLETT-PACKARD CO. HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR 05/22/1995
K915757 HEWLETT-PACKARD CO. MODELS M1722A, M1723A, M1724A DEFIBRILLATORS 07/30/1992
K915328 KATECHO, INC. GEL-TAC 06/29/1992
K012404 KATECHO, INC. K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 10/12/2001
K926175 KATECHO, INC. K-DEFIB/PACE CARBON ELECTRODE 04/15/1993
K914955 KATECHO, INC. K-DEFIB/PACE ELECTRODE 05/14/1992
K903437 KELLER MEDICAL SPECIALTIES PRODUCTS, INC. DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER 11/16/1990
K872012 LECTEC CORP. LECTEC NON-INVASIVE PACING ELECTRODE 06/29/1987
K850812 LIFE SCIENCE INSTRUMENTATION, INC. EMERGIPACE - EXTERNAL PACEMAKER 11/05/1985
K962547 MARQUETTE ELECTRONICS, INC. CARDIOSERV P 03/06/1997
K963120 MARQUETTE ELECTRONICS, INC. RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM 02/28/1997
K874090 MEDAC, INC. 300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER 12/15/1987
K864987 MEDAC, INC. DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE 03/03/1987
K864985 MEDAC, INC. DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE 03/10/1987
K874447 MEDAC, INC. DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC 01/27/1988
K864989 MEDAC, INC. ETP 180A NON-INVASIVE EXTERNAL PACEMAKER 03/03/1987
K864988 MEDAC, INC. ETP 180E NON-INVASIVE EXTERNAL PACEMAKER 03/03/1987
K864986 MEDAC, INC. ETP 300 NON-INVASIVE EXTERNAL PACEMAKER 03/03/1987
K871176 MEDAC, INC. PACE 10 NON-INVASIVE EXTERNAL PACEMAKER 04/23/1987
K000660 MEDICAL DATA ELECTRONICS ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413 03/28/2000
K961138 MEDICAL DATA ELECTRONICS ESORT II + 400 SERIES MONITOR 12/10/1996
K852958 MEDICAL DATA ELECTRONICS PACEPAC 10/11/1985
K880932 MEDICAL RESEARCH LABORATORIES, INC. MRL PACETTE, 450SLL 12/16/1988
K974034 MEDICAL RESEARCH LABORATORIES, INC. PORTABLE INTENSIVE CARE UNIT 03/02/1998
K862298 MEDTRONIC VASCULAR ALTERNATE SIZE E-Z-PACE ELECTRODE 07/11/1986
K863547 MEDTRONIC VASCULAR MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE 10/31/1986
K850791 MICROMEDICAL DEVICES, INC. MDI 2000 - PULSE GENERATOR 06/19/1985
K834262 MICROMEDICAL DEVICES, INC. TRANS-PACE 02/04/1984
K894492 NIHON KOHDEN AMERICA, INC. NKA MODEL SEC-3102 CARDIAC STIMULATOR 12/20/1989
K872778 PACIFIC RIM ENGINEERING & MFG. PACESTART 11/04/1987
K851248 PHYSIO-CONTROL CORP. AMENDMENT LIFEPAK 100, NPN 045 04/19/1985
K851247 PHYSIO-CONTROL CORP. AMENDMENT LIFEPAK 200, NPN 046 04/19/1985
K854117 PHYSIO-CONTROL CORP. AMENDMENT LIFEPAK 8, NPN 052 01/13/1986
K951593 PHYSIO-CONTROL CORP. LIFEPAK 11 12/29/1995
K840047 PHYSIO-CONTROL CORP. LIFEPAK 7D 02/04/1984
K832876 PHYSIO-CONTROL CORP. LIFEPAK 7P 01/30/1984
K853732 PHYSIO-CONTROL CORP. LIFEPAK 8 MODIFICATION 12/09/1985
K883121 PHYSIO-CONTROL CORP. QUIK-PACE II ELECTRODES 09/20/1988
K871751 PHYSIO-CONTROL CORP. QUIK-PACE NONINVASIVE PACEMAKER 12/29/1987
K912599 PHYSIO-CONTROL CORP. QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC 09/11/1991
K822246 ROSS RESEARCH, INC. NONINVASIVE TEMPORARY PACEMAKER 08/06/1982
K840353 ROSS RESEARCH, INC. PACEMAKER PULSE GENERATOR W/ELECTRODE 04/23/1984
K012218 THE LUDLOW COMPANY LP LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES 10/12/2001
K983196 TZ MEDICAL, INC. PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) 09/15/1999
K983232 TZ MEDICAL, INC. PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT 09/15/1999
K882168 UNOMED, INC. EXTERNAL PACEMAKER 2000 (EP2000) 08/19/1988
K855015 ZMI CORP. NONINVASIVE TEMP. PACEMAKER NTP-1000 03/31/1986
K885166 ZMI CORP. ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES 05/01/1989
K873402 ZMI CORP. ZOLL NTP-1200 PACER/DEFIBRILLATOR 11/23/1987
K911956 ZMI CORP. ZOLL PD-1400 PACER/DEFIBRILLATOR 07/31/1991
K950856 ZOLL MEDICAL CORP. ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000 12/29/1995


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