Clearance Summary
PERSONAL DEFIBRILLATOR received FDA 510(k) clearance under submission number K832833, 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 1984-10-26.
- Submission: K832833
- Applicant / Sponsor: Physio-Control, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5300
- Decision date: 1984-10-26
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.