Clearance Summary
KING OF HEARTS EXPRESS + AF MONITOR received FDA 510(k) clearance under submission number K020825, sponsored by Card Guard Scientific Survival , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2002-04-05.
- Submission: K020825
- Applicant / Sponsor: Card Guard Scientific Survival , Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2002-04-05
Classification & Regulation
This clearance is catalogued under FDA product code DSH and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.