Clearance Summary
HeartKey® Rhythm received FDA 510(k) clearance under submission number K233755, sponsored by B-Secur Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2024-08-16.
- Submission: K233755
- Applicant / Sponsor: B-Secur Limited
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1425
- Decision date: 2024-08-16
Classification & Regulation
This clearance is catalogued under FDA product code DQK and 21 CFR 870.1425, within the Cardiovascular review panel as a Class II device.