Clearance Summary
SONOTT FLOWLAB(R) received FDA 510(k) clearance under submission number K111730, sponsored by Em-Tec GmbH. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2012-01-06.
- Submission: K111730
- Applicant / Sponsor: Em-Tec GmbH
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2100
- Decision date: 2012-01-06
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.