LIFEPAK 9 DEFIBRILLATOR AND CARDIAC MONITOR
FDA 510(k) clearance K881153 · decided 1988-07-27
Clearance details
- K-number
- K881153
- Device name
- LIFEPAK 9 DEFIBRILLATOR AND CARDIAC MONITOR
- Applicant
- Physio-Control Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-03-17
- Decision date
- 1988-07-27
- Days to decision
- 132 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 |
|---|---|---|
| Internal Sterilizable Paddles (electrodes) and Handles without discharge control for use w recall (Z-1171-2009) | Physio Control, Inc. | 2009-04-07 |