Clearance Summary
SMARTFLOW, MODEL SFIP 2000 received FDA 510(k) clearance under submission number K003122, sponsored by Florence Medical , 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 2001-05-14.
- Submission: K003122
- Applicant / Sponsor: Florence Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1110
- Decision date: 2001-05-14
Classification & Regulation
This clearance is catalogued under FDA product code DSK and 21 CFR 870.1110, within the Cardiovascular review panel as a Class II device.