PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602
FDA 510(k) clearance K002280 · decided 2001-02-05
Clearance details
- K-number
- K002280
- Device name
- PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602
- Applicant
- Medical Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-07-26
- Decision date
- 2001-02-05
- Days to decision
- 194 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 |
|---|---|---|
| MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABL recall (Z-0460-2015) | ConMed Corporation | 2014-12-04 |