ZOLL E SERIES DEFIBRILLATOR
FDA 510(k) clearance K042007 · decided 2005-04-07
Clearance details
- K-number
- K042007
- Device name
- ZOLL E SERIES DEFIBRILLATOR
- Applicant
- Zoll Medical Corp
- Decision
- Substantially Equivalent
- Date received
- 2004-07-26
- Decision date
- 2005-04-07
- Days to decision
- 255 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Chelsmford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Zoll E Series BLS Defibrillator/Pacemaker/Monitor Software versions 7.10 and 7.11 The prod recall (Z-2294-2011) | ZOLL Medical Corporation | 2011-05-25 |
| ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6. recall (Z-1547-2010) | ZOLL Medical Corporation, World Wide Headquarters | 2010-05-07 |
| Zoll E Series Defibrillator with 12 Lead ECG, Automated external defibrillator, Software V recall (Z-1167-2008) | ZOLL Medical Corporation, World Wide Headquarters | 2008-06-28 |