Clearance Summary
MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR received FDA 510(k) clearance under submission number K012428, sponsored by Medtronic Physio-Control Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-09-28.
- Submission: K012428
- Applicant / Sponsor: Medtronic Physio-Control Corp.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.5310
- Decision date: 2001-09-28
Classification & Regulation
This clearance is catalogued under FDA product code MKJ and 21 CFR 870.5310, within the Cardiovascular review panel as a Class III device.