Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

FDA product code DRO · 84 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.5550
Review panel: CV
Implant: No
Life sustaining: Yes
Third party review: No
GMP exempt: No
Clearance span: 1982-01-18 – 2001-10-12

DRO 2001-10-12

K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85

Applicant Katecho, Inc.

K number K012404

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DRO 2001-10-12

LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES

Applicant The Ludlow Company LP

K number K012218

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DRO 2000-03-28

ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413

Applicant Medical Data Electronics

K number K000660

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DRO 1999-09-15

PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT

Applicant Tz Medical, Inc.

K number K983232

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DRO 1999-09-15

PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)

Applicant Tz Medical, Inc.

K number K983196

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DRO 1998-03-02

PORTABLE INTENSIVE CARE UNIT

Applicant Medical Research Laboratories, Inc.

K number K974034

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DRO 1997-03-06

CARDIOSERV P

Applicant Marquette Electronics, Inc.

K number K962547

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DRO 1997-02-28

RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM

Applicant Marquette Electronics, Inc.

K number K963120

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DRO 1996-12-10

ESORT II + 400 SERIES MONITOR

Applicant Medical Data Electronics

K number K961138

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DRO 1995-12-29

LIFEPAK 11

Applicant Physio-Control Corp.

K number K951593

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DRO 1995-12-29

ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000

Applicant Zoll Medical Corp

K number K950856

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DRO 1995-05-22

HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR

Applicant Hewlett-Packard Co.

K number K950483

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DRO 1993-04-15

K-DEFIB/PACE CARBON ELECTRODE

Applicant Katecho, Inc.

K number K926175

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DRO 1992-07-30

MODELS M1722A, M1723A, M1724A DEFIBRILLATORS

Applicant Hewlett-Packard Co.

K number K915757

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DRO 1992-06-29

GEL-TAC

Applicant Katecho, Inc.

K number K915328

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DRO 1992-05-14

K-DEFIB/PACE ELECTRODE

Applicant Katecho, Inc.

K number K914955

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DRO 1991-09-11

QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC

Applicant Physio-Control Corp.

K number K912599

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DRO 1991-07-31

ZOLL PD-1400 PACER/DEFIBRILLATOR

Applicant Zmi Corp.

K number K911956

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DRO 1991-05-02

MODEL 205 SHOCK-TRODE

Applicant Cardiotronics, Inc.

K number K910661

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DRO 1990-11-16

DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER

Applicant Keller Medical Specialties Products, Inc.

K number K903437

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DRO 1989-12-20

NKA MODEL SEC-3102 CARDIAC STIMULATOR

Applicant Nihon Kohden America, Inc.

K number K894492

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DRO 1989-10-26

DEFIB/PACING PADS

Applicant Conmedcorp

K number K894588

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DRO 1989-10-12

R2 PACE PAD, MODEL 480

Applicant Darox Corp.

K number K895729

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DRO 1989-10-12

R2 PACE ADAPTOR CABLE, MODEL 196

Applicant Darox Corp.

K number K895728

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DRO 1989-05-01

ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES

Applicant Zmi Corp.

K number K885166

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DRO 1989-01-12

MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE

Applicant Andover Medical, Inc.

K number K885171

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DRO 1988-12-16

MRL PACETTE, 450SLL

Applicant Medical Research Laboratories, Inc.

K number K880932

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DRO 1988-11-18

TRIAD-EP II, PUSHBUTTON, CABLE INPUT

Applicant Cardiotronics, Inc.

K number K884532

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DRO 1988-11-17

TRIAD-EP II, PLATE INPUT

Applicant Cardiotronics, Inc.

K number K884530

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DRO 1988-11-09

TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY

Applicant Cardiotronics, Inc.

K number K883304

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DRO 1988-11-09

TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE

Applicant Cardiotronics, Inc.

K number K883178

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DRO 1988-10-06

TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE

Applicant Cardiotronics, Inc.

K number K883523

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DRO 1988-09-20

QUIK-PACE II ELECTRODES

Applicant Physio-Control Corp.

K number K883121

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DRO 1988-08-30

MODEL #918 MULTI-PADS

Applicant Cardiotronics, Inc.

K number K883375

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DRO 1988-08-30

MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE

Applicant Cardiotronics, Inc.

K number K882338

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DRO 1988-08-19

EXTERNAL PACEMAKER 2000 (EP2000)

Applicant Unomed, Inc.

K number K882168

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DRO 1988-07-18

TRIAD-EP

Applicant Cardiotronics, Inc.

K number K880936

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DRO 1988-01-27

DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC

Applicant Medac, Inc.

K number K874447

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DRO 1987-12-29

QUIK-PACE NONINVASIVE PACEMAKER

Applicant Physio-Control Corp.

K number K871751

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DRO 1987-12-15

300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER

Applicant Medac, Inc.

K number K874090

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DRO 1987-11-23

ZOLL NTP-1200 PACER/DEFIBRILLATOR

Applicant Zmi Corp.

K number K873402

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DRO 1987-11-04

PACESTART

Applicant Pacific Rim Engineering & Mfg.

K number K872778

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DRO 1987-09-18

MODIFIED VERSA STIM ELECTRODE LINE

Applicant Conmedcorp

K number K872368

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DRO 1987-06-29

LECTEC NON-INVASIVE PACING ELECTRODE

Applicant Lectec Corp.

K number K872012

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DRO 1987-06-24

MODIFIED PACE*AID MODEL 53

Applicant Cardiac Resucitator Corp.

K number K871971

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DRO 1987-06-24

STAT-PAD (TM)

Applicant Cardiac Resucitator Corp.

K number K871538

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DRO 1987-06-08

MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR

Applicant Cardiac Resucitator Corp.

K number K871569

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DRO 1987-04-23

PACE 10 NON-INVASIVE EXTERNAL PACEMAKER

Applicant Medac, Inc.

K number K871176

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DRO 1987-03-10

DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE

Applicant Medac, Inc.

K number K864985

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DRO 1987-03-03

ETP 180A NON-INVASIVE EXTERNAL PACEMAKER

Applicant Medac, Inc.

K number K864989

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DRO 1987-03-03

ETP 180E NON-INVASIVE EXTERNAL PACEMAKER

Applicant Medac, Inc.

K number K864988

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DRO 1987-03-03

DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE

Applicant Medac, Inc.

K number K864987

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DRO 1987-03-03

ETP 300 NON-INVASIVE EXTERNAL PACEMAKER

Applicant Medac, Inc.

K number K864986

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DRO 1986-10-31

MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE

Applicant Medtronic Vascular

K number K863547

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DRO 1986-07-11

ALTERNATE SIZE E-Z-PACE ELECTRODE

Applicant Medtronic Vascular

K number K862298

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DRO 1986-05-01

DCI MODEL EP-2 CLINICAL STIMULATOR

Applicant Digital Cardiovascular Instruments, Inc.

K number K854196

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DRO 1986-04-30

ETP 180 CARDIAC PACEMAKER (EXTERNAL)

Applicant Biotronics Corp.

K number K860551

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DRO 1986-03-31

AMI CARDIO-PAD

Applicant Andover Medical, Inc.

K number K860283

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DRO 1986-03-31

NONINVASIVE TEMP. PACEMAKER NTP-1000

Applicant Zmi Corp.

K number K855015

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DRO 1986-02-26

AMI E-Z-PACE ELECTODE

Applicant A.M.I. Corp.

K number K854924

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DRO 1986-02-14

NI-PACER 1

Applicant Associated Medical Devices, Inc.

K number K854853

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DRO 1986-01-13

AMENDMENT LIFEPAK 8, NPN 052

Applicant Physio-Control Corp.

K number K854117

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DRO 1986-01-08

CMI 3000

Applicant Cardio Management, Inc.

K number K854233

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DRO 1985-12-09

LIFEPAK 8 MODIFICATION

Applicant Physio-Control Corp.

K number K853732

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DRO 1985-11-05

EMERGIPACE - EXTERNAL PACEMAKER

Applicant Life Science Instrumentation, Inc.

K number K850812

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DRO 1985-10-11

PACEPAC

Applicant Medical Data Electronics

K number K852958

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DRO 1985-06-19

MDI 2000 - PULSE GENERATOR

Applicant Micromedical Devices, Inc.

K number K850791

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DRO 1985-04-19

AMENDMENT LIFEPAK 100, NPN 045

Applicant Physio-Control Corp.

K number K851248

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DRO 1985-04-19

AMENDMENT LIFEPAK 200, NPN 046

Applicant Physio-Control Corp.

K number K851247

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DRO 1985-03-06

PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY &

Applicant Cardiac Resucitator Corp.

K number K850596

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DRO 1985-02-14

HEART AID MODEL 97

Applicant Cardiac Resucitator Corp.

K number K850170

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DRO 1985-01-24

PACE AID MODEL 53

Applicant Cardiac Resucitator Corp.

K number K844811

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DRO 1984-12-17

PACE *AID MODEL 52

Applicant Cardiac Resucitator Corp.

K number K843547

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DRO 1984-11-19

HEART-AID MODEL 80

Applicant Cardiac Resucitator Corp.

K number K843358

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DRO 1984-04-23

PACEMAKER PULSE GENERATOR W/ELECTRODE

Applicant Ross Research, Inc.

K number K840353

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DRO 1984-02-04

LIFEPAK 7D

Applicant Physio-Control Corp.

K number K840047

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DRO 1984-02-04

TRANS-PACE

Applicant Micromedical Devices, Inc.

K number K834262

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DRO 1984-01-30

LIFEPAK 7P

Applicant Physio-Control Corp.

K number K832876

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DRO 1982-08-06

NONINVASIVE TEMPORARY PACEMAKER

Applicant Ross Research, Inc.

K number K822246

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DRO 1982-08-06

HEART*AID, ALS, MODEL 95

Applicant Cardiac Resucitator Corp.

K number K821673

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DRO 1982-08-06

HEART AID #90

Applicant Cardiac Resucitator Corp.

K number K821152

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DRO 1982-08-06

HEART *AID, #80

Applicant Cardiac Resucitator Corp.

K number K820609

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DRO 1982-08-06

PACE* AID MODEL 50

Applicant Cardiac Resucitator Corp.

K number K820507

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DRO 1982-01-18

PACE *AID

Applicant Cardiac Resucitator Corp.

K number K813553

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