Clearance Summary
FloPatch (FP110) received FDA 510(k) clearance under submission number K191388, sponsored by Flosonics Medical (R/A 1929803 Ontario Corp.). The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2019-06-21.
- Submission: K191388
- Applicant / Sponsor: Flosonics Medical (R/A 1929803 Ontario Corp.)
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2100
- Decision date: 2019-06-21
Classification & Regulation
This clearance is catalogued under FDA product code DPW and 21 CFR 870.2100, within the Cardiovascular review panel as a Class II device.