LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR
FDA 510(k) clearance K945511 · decided 1995-09-26
Clearance details
- K-number
- K945511
- Device name
- LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR
- Applicant
- Physio-Control Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-11-09
- Decision date
- 1995-09-26
- Days to decision
- 321 days
- Clearance type
- Traditional
- Product code
- MPE
- Device class
- 2
- Regulation number
- 870.5550
- 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
No recalls on record reference this clearance.