Clearance Summary
B-Secur HeartKey Software Library received FDA 510(k) clearance under submission number K200884, sponsored by B-Secur , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-12-07.
- Submission: K200884
- Applicant / Sponsor: B-Secur , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2020-12-07
Classification & Regulation
This clearance is catalogued under FDA product code DPS and 21 CFR 870.2340, within the Cardiovascular review panel as a Class II device.