MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
FDA 510(k) clearance K012428 · decided 2001-09-28
Clearance details
- K-number
- K012428
- Device name
- MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
- Applicant
- Medtronic Physio-Control Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-31
- Decision date
- 2001-09-28
- Days to decision
- 59 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 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 30 recall (Z-1633-2020) | Physio-Control, Inc. | 2020-04-01 |
| LIFEPAK 500 automated external defibrillator recall (Z-0886-04) | Medtronic Physio Control Corp | 2004-07-20 |