LIFEPAK, MODEL 1000
FDA 510(k) clearance K042404 · decided 2005-12-22
Clearance details
- K-number
- K042404
- Device name
- LIFEPAK, MODEL 1000
- Applicant
- Medtronic Emergency Response Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-03
- Decision date
- 2005-12-22
- Days to decision
- 475 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 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) i recall (Z-1660-2014) | Physio-Control, Inc. | 2014-05-23 |
| LIFEPAK 1000 defibrillator - portable battery powered semi-automated model that can be ope recall (Z-1656-2008) | Physio Control, Inc. | 2008-09-16 |