LIFEPAK 12 BIPHASIC
FDA 510(k) clearance K991910 · decided 1999-09-03
Clearance details
- K-number
- K991910
- Device name
- LIFEPAK 12 BIPHASIC
- Applicant
- Physio-Control Corp.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1999-06-07
- Decision date
- 1999-09-03
- Days to decision
- 88 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 |
|---|---|---|
| Physio-Control LIFEPAK 12 defibrillator/monitor. The LIFEPAK12 defibrillator/monitor serie recall (Z-1858-2008) | Physio Control, Inc. | 2008-09-11 |
| LIFEPAK 12 defibrillator/ monitors biphasic recall (Z-0495-05) | Medtronic Emergency Response Systems, Inc. | 2005-02-03 |
| LIFEPAK 12 defibrillator/monitor is a portable, battery operated, complete acute cardiac c recall (Z-0542-03) | Medtronic Physio Control Corp | 2003-02-05 |