DRO — Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) Class II
FDA product code DRO covers "Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)", a Class II medical device regulated under 21 CFR 870.5550. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DRO
- Device Class
- Class II
- Regulation Number
- 870.5550
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K012404 | katecho | K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 | October 12, 2001 |
| K012218 | ludlow company | LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES | October 12, 2001 |
| K000660 | medical data electronics | ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS | March 28, 2000 |
| K983196 | tz medical | PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) | September 15, 1999 |
| K983232 | tz medical | PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2 | September 15, 1999 |
| K974034 | medical research laboratories | PORTABLE INTENSIVE CARE UNIT | March 2, 1998 |
| K962547 | marquette electronics | CARDIOSERV P | March 6, 1997 |
| K963120 | marquette electronics | RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM | February 28, 1997 |
| K961138 | medical data electronics | ESORT II + 400 SERIES MONITOR | December 10, 1996 |
| K951593 | physio-control | LIFEPAK 11 | December 29, 1995 |
| K950856 | zoll medical | ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY | December 29, 1995 |
| K950483 | hewlett-packard | HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR | May 22, 1995 |
| K926175 | katecho | K-DEFIB/PACE CARBON ELECTRODE | April 15, 1993 |
| K915757 | hewlett-packard | MODELS M1722A, M1723A, M1724A DEFIBRILLATORS | July 30, 1992 |
| K915328 | katecho | GEL-TAC | June 29, 1992 |
| K914955 | katecho | K-DEFIB/PACE ELECTRODE | May 14, 1992 |
| K912599 | physio-control | QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC | September 11, 1991 |
| K911956 | zmi | ZOLL PD-1400 PACER/DEFIBRILLATOR | July 31, 1991 |
| K910661 | cardiotronics | MODEL 205 SHOCK-TRODE | May 2, 1991 |
| K903437 | keller medical specialties products | DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER | November 16, 1990 |