Clearance Summary
Faros Mobile received FDA 510(k) clearance under submission number K182030, sponsored by Bittium Biosignals , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2018-11-08.
- Submission: K182030
- Applicant / Sponsor: Bittium Biosignals , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2018-11-08
Classification & Regulation
This clearance is catalogued under FDA product code MLO and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.