MODIFICATION TO POWERHEART ECD
FDA 510(k) clearance K060934 · decided 2006-05-15
Clearance details
- K-number
- K060934
- Device name
- MODIFICATION TO POWERHEART ECD
- Applicant
- Cardiac Science Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-04-05
- Decision date
- 2006-05-15
- Days to decision
- 40 days
- Clearance type
- Special
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bothell, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Responder 2000 Defibrillator/Monitor, models 2025653, 2026109, and 2026114 that were ma recall (Z-0589-2011) | Cardiac Science Corporation | 2010-12-10 |
| Responder 2000 Defibrillator/Monitor Models: 2025653, 2026109, and 2026114. Intended use: recall (Z-1683-2010) | Cardiac Science Corporation | 2010-05-26 |