LIFEPAK 12 DEFIBRILLATOR/MONITOR
FDA 510(k) clearance K063510 · decided 2007-01-26
Clearance details
- K-number
- K063510
- Device name
- LIFEPAK 12 DEFIBRILLATOR/MONITOR
- Applicant
- Medtronic Emergency Response Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-11-20
- Decision date
- 2007-01-26
- Days to decision
- 67 days
- Clearance type
- Special
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Biphasic LIFEPAK 12 defibrillator / monitor. recall (Z-0811-2010) | Physio Control, Inc. | 2010-02-22 |
| Physio-Control LIFEPAK 12 defibrillator/monitor is indicated for the termination of certai recall (Z-1904-2008) | Physio Control, Inc. | 2008-09-16 |