Clearance Summary
Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors received FDA 510(k) clearance under submission number K182503, sponsored by Physio-Control, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2019-06-03.
- Submission: K182503
- Applicant / Sponsor: Physio-Control, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5300
- Decision date: 2019-06-03
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.