Clearance Summary
SONO TT ULTRASONIC FLOWCOMPUTER received FDA 510(k) clearance under submission number K040909, sponsored by Em-Tec GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-04-20.
- Submission: K040909
- Applicant / Sponsor: Em-Tec GmbH
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2100
- Decision date: 2004-04-20
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.