Clearance Summary
LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR received FDA 510(k) clearance under submission number K945511, sponsored by Physio-Control Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1995-09-26.
- Submission: K945511
- Applicant / Sponsor: Physio-Control Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5550
- Decision date: 1995-09-26
Classification & Regulation
This clearance is catalogued under FDA product code MPE and 21 CFR 870.5550, within the Cardiovascular review panel as a Class II device.