LIFEPAK 12
FDA 510(k) clearance K040775 · decided 2004-04-23
Clearance details
- K-number
- K040775
- Device name
- LIFEPAK 12
- Applicant
- Medtronic Physio-Control Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-03-26
- Decision date
- 2004-04-23
- Days to decision
- 28 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 |
|---|---|---|
| LIFEPAK 12 defibrillator/ monitors biphasic recall (Z-0495-05) | Medtronic Emergency Response Systems, Inc. | 2005-02-03 |