DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE
FDA 510(k) clearance K864987 · decided 1987-03-03
Clearance details
- K-number
- K864987
- Device name
- DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE
- Applicant
- Medac, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-22
- Decision date
- 1987-03-03
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- DRO
- Device class
- 2
- Regulation number
- 870.5550
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tualatin, OR, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES (K012218) | The Ludlow Company LP | 2001-10-12 |
| K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 (K012404) | Katecho, Inc. | 2001-10-12 |
| ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413 (K000660) | Medical Data Electronics | 2000-03-28 |
| PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) (K983196) | Tz Medical, Inc. | 1999-09-15 |
| PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT (K983232) | Tz Medical, Inc. | 1999-09-15 |
| PORTABLE INTENSIVE CARE UNIT (K974034) | Medical Research Laboratories, Inc. | 1998-03-02 |
| CARDIOSERV P (K962547) | Marquette Electronics, Inc. | 1997-03-06 |
| RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM (K963120) | Marquette Electronics, Inc. | 1997-02-28 |
| ESORT II + 400 SERIES MONITOR (K961138) | Medical Data Electronics | 1996-12-10 |
| ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000 (K950856) | Zoll Medical Corp | 1995-12-29 |
| LIFEPAK 11 (K951593) | Physio-Control Corp. | 1995-12-29 |
| HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR (K950483) | Hewlett-Packard Co. | 1995-05-22 |
Recalls involving this device
No recalls on record reference this clearance.