LIFEPAK 20 DEFIBRILLATOR/ MONITOR
FDA 510(k) clearance K063119 · decided 2006-12-22
Clearance details
- K-number
- K063119
- Device name
- LIFEPAK 20 DEFIBRILLATOR/ MONITOR
- Applicant
- Medtronic Emergency Response Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-12
- Decision date
- 2006-12-22
- Days to decision
- 71 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 |
|---|---|---|
| Physio-Control LIFEPAK 20 defibrillator/monitor is indicated for the termination of certai recall (Z-1905-2008) | Physio Control, Inc. | 2008-09-16 |
| Physio-Control LIFEPAK 20e defibrillator/monitor, sold internationally only, is indicated recall (Z-1906-2008) | Physio Control, Inc. | 2008-09-16 |
| Physio-Control LIFEPAK 20 defibrillator/monitor. This product is an external defibrillator recall (Z-2009-2008) | Physio Control, Inc. | 2008-09-08 |
| Physio-Control LIFEPAK 20e defibrillator/monitor. This product is an external defibrillato recall (Z-2010-2008) | Physio Control, Inc. | 2008-09-08 |
| Keypad replacement for LIFEPAK20 or LIFEPAK20e. This product is an external defibrillator. recall (Z-2011-2008) | Physio Control, Inc. | 2008-09-08 |