LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
FDA 510(k) clearance K052057 · decided 2006-02-17
Clearance details
- K-number
- K052057
- Device name
- LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
- Applicant
- Medtronic Emergency Response Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-07-29
- Decision date
- 2006-02-17
- Days to decision
- 203 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 30 recall (Z-1633-2020) | Physio-Control, Inc. | 2020-04-01 |
| The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that us recall (Z-1773-2013) | Physio Control, Inc. | 2013-07-19 |
| The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that us recall (Z-2885-2011) | Physio Control, Inc. | 2011-07-26 |