Clearance Summary
MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER received FDA 510(k) clearance under submission number K012274, sponsored by Medtronic 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 2002-02-05.
- Submission: K012274
- Applicant / Sponsor: Medtronic Physio-Control Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5300
- Decision date: 2002-02-05
Classification & Regulation
This clearance is catalogued under FDA product code LDD and 21 CFR 870.5300, within the Cardiovascular review panel as a Class II device.