FDA Product Code
FDA Product Code DRO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5550
510(k) Clearances — 84 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K012218 | LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES | The Ludlow Company LP | 2001-10-12 | Traditional | PDF ↗ |
| K012404 | K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 | Katecho, Inc. | 2001-10-12 | Traditional | PDF ↗ |
| K000660 | ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413 | Medical Data Electronics | 2000-03-28 | Special | PDF ↗ |
| K983196 | PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) | Tz Medical, Inc. | 1999-09-15 | Traditional | PDF ↗ |
| K983232 | PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT | Tz Medical, Inc. | 1999-09-15 | Traditional | PDF ↗ |
| K974034 | PORTABLE INTENSIVE CARE UNIT | Medical Research Laboratories, Inc. | 1998-03-02 | Traditional | PDF ↗ |
| K962547 | CARDIOSERV P | Marquette Electronics, Inc. | 1997-03-06 | Traditional | PDF ↗ |
| K963120 | RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM | Marquette Electronics, Inc. | 1997-02-28 | Traditional | PDF ↗ |
| K961138 | ESORT II + 400 SERIES MONITOR | Medical Data Electronics | 1996-12-10 | Traditional | PDF ↗ |
| K951593 | LIFEPAK 11 | Physio-Control Corp. | 1995-12-29 | Traditional | PDF ↗ |
| K950856 | ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000 | Zoll Medical Corp | 1995-12-29 | Traditional | PDF ↗ |
| K950483 | HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR | Hewlett-Packard Co. | 1995-05-22 | Traditional | PDF ↗ |
| K926175 | K-DEFIB/PACE CARBON ELECTRODE | Katecho, Inc. | 1993-04-15 | Traditional | PDF ↗ |
| K915757 | MODELS M1722A, M1723A, M1724A DEFIBRILLATORS | Hewlett-Packard Co. | 1992-07-30 | Traditional | PDF ↗ |
| K915328 | GEL-TAC | Katecho, Inc. | 1992-06-29 | Traditional | PDF ↗ |
| K914955 | K-DEFIB/PACE ELECTRODE | Katecho, Inc. | 1992-05-14 | Traditional | PDF ↗ |
| K912599 | QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC | Physio-Control Corp. | 1991-09-11 | Traditional | PDF ↗ |
| K911956 | ZOLL PD-1400 PACER/DEFIBRILLATOR | Zmi Corp. | 1991-07-31 | Traditional | PDF ↗ |
| K910661 | MODEL 205 SHOCK-TRODE | Cardiotronics, Inc. | 1991-05-02 | Traditional | PDF ↗ |
| K903437 | DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER | Keller Medical Specialties Products, Inc. | 1990-11-16 | Traditional | PDF ↗ |
| K894492 | NKA MODEL SEC-3102 CARDIAC STIMULATOR | Nihon Kohden America, Inc. | 1989-12-20 | Traditional | PDF ↗ |
| K894588 | DEFIB/PACING PADS | Conmedcorp | 1989-10-26 | Traditional | PDF ↗ |
| K895728 | R2 PACE ADAPTOR CABLE, MODEL 196 | Darox Corp. | 1989-10-12 | Traditional | PDF ↗ |
| K895729 | R2 PACE PAD, MODEL 480 | Darox Corp. | 1989-10-12 | Traditional | PDF ↗ |
| K885166 | ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES | Zmi Corp. | 1989-05-01 | Traditional | PDF ↗ |
| K885171 | MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE | Andover Medical, Inc. | 1989-01-12 | Traditional | PDF ↗ |
| K880932 | MRL PACETTE, 450SLL | Medical Research Laboratories, Inc. | 1988-12-16 | Traditional | PDF ↗ |
| K884532 | TRIAD-EP II, PUSHBUTTON, CABLE INPUT | Cardiotronics, Inc. | 1988-11-18 | Traditional | PDF ↗ |
| K884530 | TRIAD-EP II, PLATE INPUT | Cardiotronics, Inc. | 1988-11-17 | Traditional | PDF ↗ |
| K883178 | TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE | Cardiotronics, Inc. | 1988-11-09 | Traditional | PDF ↗ |
| K883304 | TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY | Cardiotronics, Inc. | 1988-11-09 | Traditional | PDF ↗ |
| K883523 | TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE | Cardiotronics, Inc. | 1988-10-06 | Traditional | PDF ↗ |
| K883121 | QUIK-PACE II ELECTRODES | Physio-Control Corp. | 1988-09-20 | Traditional | PDF ↗ |
| K882338 | MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE | Cardiotronics, Inc. | 1988-08-30 | Traditional | PDF ↗ |
| K883375 | MODEL #918 MULTI-PADS | Cardiotronics, Inc. | 1988-08-30 | Traditional | PDF ↗ |
| K882168 | EXTERNAL PACEMAKER 2000 (EP2000) | Unomed, Inc. | 1988-08-19 | Traditional | PDF ↗ |
| K880936 | TRIAD-EP | Cardiotronics, Inc. | 1988-07-18 | Traditional | PDF ↗ |
| K874447 | DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC | Medac, Inc. | 1988-01-27 | Traditional | PDF ↗ |
| K871751 | QUIK-PACE NONINVASIVE PACEMAKER | Physio-Control Corp. | 1987-12-29 | Traditional | PDF ↗ |
| K874090 | 300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER | Medac, Inc. | 1987-12-15 | Traditional | PDF ↗ |
| K873402 | ZOLL NTP-1200 PACER/DEFIBRILLATOR | Zmi Corp. | 1987-11-23 | Traditional | PDF ↗ |
| K872778 | PACESTART | Pacific Rim Engineering & Mfg. | 1987-11-04 | Traditional | PDF ↗ |
| K872368 | MODIFIED VERSA STIM ELECTRODE LINE | Conmedcorp | 1987-09-18 | Traditional | PDF ↗ |
| K872012 | LECTEC NON-INVASIVE PACING ELECTRODE | Lectec Corp. | 1987-06-29 | Traditional | PDF ↗ |
| K871538 | STAT-PAD (TM) | Cardiac Resucitator Corp. | 1987-06-24 | Traditional | PDF ↗ |
| K871971 | MODIFIED PACE*AID MODEL 53 | Cardiac Resucitator Corp. | 1987-06-24 | Traditional | PDF ↗ |
| K871569 | MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR | Cardiac Resucitator Corp. | 1987-06-08 | Traditional | PDF ↗ |
| K871176 | PACE 10 NON-INVASIVE EXTERNAL PACEMAKER | Medac, Inc. | 1987-04-23 | Traditional | PDF ↗ |
| K864985 | DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE | Medac, Inc. | 1987-03-10 | Traditional | PDF ↗ |
| K864989 | ETP 180A NON-INVASIVE EXTERNAL PACEMAKER | Medac, Inc. | 1987-03-03 | Traditional | PDF ↗ |
| K864986 | ETP 300 NON-INVASIVE EXTERNAL PACEMAKER | Medac, Inc. | 1987-03-03 | Traditional | PDF ↗ |
| K864988 | ETP 180E NON-INVASIVE EXTERNAL PACEMAKER | Medac, Inc. | 1987-03-03 | Traditional | PDF ↗ |
| K864987 | DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE | Medac, Inc. | 1987-03-03 | Traditional | PDF ↗ |
| K863547 | MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE | Medtronic Vascular | 1986-10-31 | Traditional | PDF ↗ |
| K862298 | ALTERNATE SIZE E-Z-PACE ELECTRODE | Medtronic Vascular | 1986-07-11 | Traditional | PDF ↗ |
| K854196 | DCI MODEL EP-2 CLINICAL STIMULATOR | Digital Cardiovascular Instruments, Inc. | 1986-05-01 | Traditional | PDF ↗ |
| K860551 | ETP 180 CARDIAC PACEMAKER (EXTERNAL) | Biotronics Corp. | 1986-04-30 | Traditional | PDF ↗ |
| K860283 | AMI CARDIO-PAD | Andover Medical, Inc. | 1986-03-31 | Traditional | PDF ↗ |
| K855015 | NONINVASIVE TEMP. PACEMAKER NTP-1000 | Zmi Corp. | 1986-03-31 | Traditional | PDF ↗ |
| K854924 | AMI E-Z-PACE ELECTODE | A.M.I. Corp. | 1986-02-26 | Traditional | PDF ↗ |
| K854853 | NI-PACER 1 | Associated Medical Devices, Inc. | 1986-02-14 | Traditional | PDF ↗ |
| K854117 | AMENDMENT LIFEPAK 8, NPN 052 | Physio-Control Corp. | 1986-01-13 | Traditional | PDF ↗ |
| K854233 | CMI 3000 | Cardio Management, Inc. | 1986-01-08 | Traditional | PDF ↗ |
| K853732 | LIFEPAK 8 MODIFICATION | Physio-Control Corp. | 1985-12-09 | Traditional | PDF ↗ |
| K850812 | EMERGIPACE - EXTERNAL PACEMAKER | Life Science Instrumentation, Inc. | 1985-11-05 | Traditional | PDF ↗ |
| K852958 | PACEPAC | Medical Data Electronics | 1985-10-11 | Traditional | PDF ↗ |
| K850791 | MDI 2000 - PULSE GENERATOR | Micromedical Devices, Inc. | 1985-06-19 | Traditional | PDF ↗ |
| K851248 | AMENDMENT LIFEPAK 100, NPN 045 | Physio-Control Corp. | 1985-04-19 | Traditional | PDF ↗ |
| K851247 | AMENDMENT LIFEPAK 200, NPN 046 | Physio-Control Corp. | 1985-04-19 | Traditional | PDF ↗ |
| K850596 | PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY & | Cardiac Resucitator Corp. | 1985-03-06 | Traditional | PDF ↗ |
| K850170 | HEART AID MODEL 97 | Cardiac Resucitator Corp. | 1985-02-14 | Traditional | PDF ↗ |
| K844811 | PACE AID MODEL 53 | Cardiac Resucitator Corp. | 1985-01-24 | Traditional | PDF ↗ |
| K843547 | PACE *AID MODEL 52 | Cardiac Resucitator Corp. | 1984-12-17 | Traditional | PDF ↗ |
| K843358 | HEART-AID MODEL 80 | Cardiac Resucitator Corp. | 1984-11-19 | Traditional | PDF ↗ |
| K840353 | PACEMAKER PULSE GENERATOR W/ELECTRODE | Ross Research, Inc. | 1984-04-23 | Traditional | PDF ↗ |
| K834262 | TRANS-PACE | Micromedical Devices, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K840047 | LIFEPAK 7D | Physio-Control Corp. | 1984-02-04 | Traditional | PDF ↗ |
| K832876 | LIFEPAK 7P | Physio-Control Corp. | 1984-01-30 | Traditional | PDF ↗ |
| K821152 | HEART AID #90 | Cardiac Resucitator Corp. | 1982-08-06 | Traditional | PDF ↗ |
| K820507 | PACE* AID MODEL 50 | Cardiac Resucitator Corp. | 1982-08-06 | Traditional | PDF ↗ |
| K821673 | HEART*AID, ALS, MODEL 95 | Cardiac Resucitator Corp. | 1982-08-06 | Traditional | PDF ↗ |
| K820609 | HEART *AID, #80 | Cardiac Resucitator Corp. | 1982-08-06 | Traditional | PDF ↗ |
| K822246 | NONINVASIVE TEMPORARY PACEMAKER | Ross Research, Inc. | 1982-08-06 | Traditional | PDF ↗ |
| K813553 | PACE *AID | Cardiac Resucitator Corp. | 1982-01-18 | Traditional | PDF ↗ |
Product code DRO · Class II · Cardiovascular. Data: openFDA.