Clearance Summary
BB-613-BPM received FDA 510(k) clearance under submission number K241066, sponsored by Biobeat Technologies , 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 2025-01-14.
- Submission: K241066
- Applicant / Sponsor: Biobeat Technologies , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2025-01-14
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.