Product code DRO
- Device name
- Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.5550
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K012218 | LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES | The Ludlow Company LP | 2001-10-12 |
| K012404 | K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 | Katecho, Inc. | 2001-10-12 |
| K000660 | ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413 | Medical Data Electronics | 2000-03-28 |
| K983196 | PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) | Tz Medical, Inc. | 1999-09-15 |
| K983232 | PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT | Tz Medical, Inc. | 1999-09-15 |
| K974034 | PORTABLE INTENSIVE CARE UNIT | Medical Research Laboratories, Inc. | 1998-03-02 |
| K962547 | CARDIOSERV P | Marquette Electronics, Inc. | 1997-03-06 |
| K963120 | RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM | Marquette Electronics, Inc. | 1997-02-28 |
| K961138 | ESORT II + 400 SERIES MONITOR | Medical Data Electronics | 1996-12-10 |
| K951593 | LIFEPAK 11 | Physio-Control Corp. | 1995-12-29 |
| K950856 | ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000 | Zoll Medical Corp | 1995-12-29 |
| K950483 | HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR | Hewlett-Packard Co. | 1995-05-22 |
| K926175 | K-DEFIB/PACE CARBON ELECTRODE | Katecho, Inc. | 1993-04-15 |
| K915757 | MODELS M1722A, M1723A, M1724A DEFIBRILLATORS | Hewlett-Packard Co. | 1992-07-30 |
| K915328 | GEL-TAC | Katecho, Inc. | 1992-06-29 |
| K914955 | K-DEFIB/PACE ELECTRODE | Katecho, Inc. | 1992-05-14 |
| K912599 | QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC | Physio-Control Corp. | 1991-09-11 |
| K911956 | ZOLL PD-1400 PACER/DEFIBRILLATOR | Zmi Corp. | 1991-07-31 |
| K910661 | MODEL 205 SHOCK-TRODE | Cardiotronics, Inc. | 1991-05-02 |
| K903437 | DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER | Keller Medical Specialties Products, Inc. | 1990-11-16 |
| K894492 | NKA MODEL SEC-3102 CARDIAC STIMULATOR | Nihon Kohden America, Inc. | 1989-12-20 |
| K894588 | DEFIB/PACING PADS | Conmedcorp | 1989-10-26 |
| K895728 | R2 PACE ADAPTOR CABLE, MODEL 196 | Darox Corp. | 1989-10-12 |
| K895729 | R2 PACE PAD, MODEL 480 | Darox Corp. | 1989-10-12 |
| K885166 | ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES | Zmi Corp. | 1989-05-01 |
| K885171 | MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE | Andover Medical, Inc. | 1989-01-12 |
| K880932 | MRL PACETTE, 450SLL | Medical Research Laboratories, Inc. | 1988-12-16 |
| K884532 | TRIAD-EP II, PUSHBUTTON, CABLE INPUT | Cardiotronics, Inc. | 1988-11-18 |
| K884530 | TRIAD-EP II, PLATE INPUT | Cardiotronics, Inc. | 1988-11-17 |
| K883304 | TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY | Cardiotronics, Inc. | 1988-11-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10811331010319 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10811331010692 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10811331010685 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10811331010678 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10811331010661 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10811331010654 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10811331010647 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10811331010463 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10811331010456 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10811331010449 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10811331010432 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10811331010425 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10811331010401 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10811331010302 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10811331010326 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10811331010333 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10811331010340 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10811331010357 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10811331010364 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10811331010371 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10811331010388 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10811331010395 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10811331010418 | Defibrillation Electrodes | Tz Medical, Inc. | 2020-12-30 |
| 10884521140912 | Medi-Trace Cadence | Cardinal Health, Inc. | 2014-09-19 |
| 20884527022301 | Medi-Trace Cadence | Cardinal Health, Inc. | 2014-09-19 |
| 20884527022325 | Medi-Trace Cadence | Cardinal Health, Inc. | 2014-09-19 |
| 20884527015587 | Kendall | Cardinal Health, Inc. | 2014-09-18 |
| 20884527015594 | Kendall | Cardinal Health, Inc. | 2014-09-18 |
| 20884527015600 | Kendall | Cardinal Health, Inc. | 2014-09-18 |
| 20884527015617 | Kendall | Cardinal Health, Inc. | 2014-09-18 |