Clearance Summary
BB-613 Watch Oximeter received FDA 510(k) clearance under submission number K181006, sponsored by Bio-Beat 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 2018-09-21.
- Submission: K181006
- Applicant / Sponsor: Bio-Beat Technologies , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2018-09-21
Classification & Regulation
This clearance is catalogued under FDA product code DQA and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.