LIFEPAK 10 DEFIBRILLATOR/MONITOR
FDA 510(k) clearance K890079 · decided 1989-02-23
Clearance details
- K-number
- K890079
- Device name
- LIFEPAK 10 DEFIBRILLATOR/MONITOR
- Applicant
- Physio-Control Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-01-04
- Decision date
- 1989-02-23
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- LDD
- Device class
- 2
- Regulation number
- 870.5300
- 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 |
|---|---|---|
| FASTPAK batteries labeled Manufactured for Medtronic Physio-Control 11811 Willows Rd, Redm recall (Z-1567-2008) | Physio Control, Inc. | 2008-08-24 |