FDA Product Code
FDA Product Code MKJ — Clearance Directory
- Device Class
- Class III
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5310
510(k) Clearances — 228 records · page 3 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K960329 | DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD | Contour Medical Technology, Inc. | 1996-07-02 | Traditional | PDF ↗ |
| K954957 | CODEMASTER XL + XL W/SHOCK ADVISORY OPTION | Hewlett-Packard Co. | 1996-05-07 | Traditional | PDF ↗ |
| K953204 | PEDIATRIC QUIK-COMBO | Physio-Control Corp. | 1996-01-11 | Traditional | PDF ↗ |
| K954609 | HEARTSTART 911 | Laerdal Medical Corp. | 1996-01-04 | Traditional | PDF ↗ |
| K954504 | K-DEFIB/PACE PEDIATRIC ELECTRODE | Katecho, Inc. | 1995-11-17 | Traditional | PDF ↗ |
| K952101 | MARQUETTE DEFIB ELECTRODES | Marquette Electronics, Inc. | 1995-09-07 | Traditional | PDF ↗ |
| K941262 | MARQUETTE DEFIB ELECTRODE | Marquette Electronics, Inc. | 1995-04-20 | Traditional | PDF ↗ |
| K942344 | ZOLL PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR | Zoll Medical Corp | 1995-03-13 | Traditional | PDF ↗ |
| K942850 | ZOLL POWERBASE(TM) | Zoll Medical Corp | 1995-02-10 | Traditional | PDF ↗ |
| K940445 | VIVALINK AED DEFIBRILLATOR | Survivalink Corp. | 1995-02-09 | Traditional | PDF ↗ |
| K934692 | K-DEFIB/PACE PEDIATRIC ELECTRODE | Katecho, Inc. | 1995-01-24 | Traditional | PDF ↗ |
| K943698 | STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES | Zoll Medical Corp | 1994-12-28 | Traditional | PDF ↗ |
| K935922 | 360 SLX ADVISORY DEFIBRILLATOR | Medical Research Laboratories, Inc. | 1994-12-22 | Traditional | PDF ↗ |
| K941970 | FAST-PATCH | Physio-Control Corp. | 1994-12-07 | Traditional | PDF ↗ |
| K925936 | LIFEPAK 300 AUTOMATIC ADVISORY DEFRILLATOR | Physio-Control Corp. | 1994-06-08 | Traditional | PDF ↗ |
| K932028 | PD-1400 PACER/DEFIBRILLATOR | Zoll Medical Corp | 1993-10-08 | Traditional | PDF ↗ |
| K932931 | D1400 DEFIBRILLATOR W/ DEFIBRILLATION ADVISORY OPT | Zoll Medical Corp | 1993-10-07 | Traditional | PDF ↗ |
| K926172 | SERIES 1500 DEFIBRILLATOR, MODIFICATION | Marquette Electronics, Inc. | 1993-02-25 | Traditional | PDF ↗ |
| K896919 | HEARTSTART 3000 | Laerdal Medical Corp. | 1990-05-03 | Traditional | PDF ↗ |
| K892005 | SHOCK ADVISORY ADAPTER FOR USE W/LIFEPAK 9 | Physio-Control Corp. | 1989-06-20 | Traditional | PDF ↗ |
| K892065 | LIFEPAK 250 DEFIBRILLATOR/MONITOR | Physio-Control Corp. | 1989-06-05 | Traditional | PDF ↗ |
| K882067 | MARQUETTE 1200 DEFIBRILLATOR | Marquette Electronics, Inc. | 1988-11-17 | Traditional | PDF ↗ |
| K883584 | FIRST MEDIC MODE 610 | First Medical Devices Corp. | 1988-10-06 | Traditional | PDF ↗ |
| K883344 | HEARTSTART 1000S | Laerdal Mfg. Corp. | 1988-09-12 | Traditional | PDF ↗ |
| K883341 | HEARTSTART 1000 | Laerdal Mfg. Corp. | 1988-09-12 | Traditional | PDF ↗ |
| K870622 | HEART*AID 1000 | Cardiac Resucitator Corp. | 1987-04-10 | Traditional | PDF ↗ |
| K860676 | HEARTSTART 2000 | First Medical Devices Corp. | 1986-04-30 | Traditional | PDF ↗ |
| K853564 | LIFEPAK 200 | Physio-Control Corp. | 1985-10-11 | Traditional | PDF ↗ |
Product code MKJ · Class III · Cardiovascular. Data: openFDA.