LIFE PAK 12
FDA 510(k) clearance K973486 · decided 1998-01-09
Clearance details
- K-number
- K973486
- Device name
- LIFE PAK 12
- Applicant
- Physio-Control Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-09-15
- Decision date
- 1998-01-09
- Days to decision
- 116 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 |
|---|---|---|
| 12-lead ECG Cable Assembly contains the following cable and attachments: Main Cable with L recall (Z-2625-2011) | Physio Control, Inc. | 2011-06-22 |
| FASTPAK batteries labeled Manufactured for Medtronic Physio-Control 11811 Willows Rd, Redm recall (Z-1567-2008) | Physio Control, Inc. | 2008-08-24 |
| LIFEPAK 12 defibrillator/monitor is a portable, battery operated, complete acute cardiac c recall (Z-0542-03) | Medtronic Physio Control Corp | 2003-02-05 |