POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS
FDA 510(k) clearance K102496 · decided 2011-06-09
Clearance details
- K-number
- K102496
- Device name
- POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS
- Applicant
- Cardiac Science Corporation
- Decision
- Substantially Equivalent
- Date received
- 2010-08-31
- Decision date
- 2011-06-09
- Days to decision
- 282 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 |
|---|---|---|
| 9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, recall (Z-0829-2016) | Cardiac Science Corporation | 2016-03-09 |
| Powerheart G3 Automated External Defibrillators (Non-Wearable) and include the following m recall (Z-1057-2012) | Cardiac Science Corporation | 2012-02-27 |