K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A
FDA 510(k) clearance K003228 · decided 2000-12-14
Clearance details
- K-number
- K003228
- Device name
- K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A
- Applicant
- Katecho, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-10-16
- Decision date
- 2000-12-14
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Des Moines, IA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HeartStart Pads Pediatric Plus, Pediatric Plus Multifunction Defibrillation Electrode Pads recall (Z-0321-06) | Philips Medical Systems | 2005-12-23 |