Clearance Summary
RIGHT VENTRICULAR EJECTION FRACTION- received FDA 510(k) clearance under submission number K842105, sponsored by American Edwards Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1985-01-15.
- Submission: K842105
- Applicant / Sponsor: American Edwards Laboratories
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1435
- Decision date: 1985-01-15
Classification & Regulation
This clearance is catalogued under FDA product code DXG and 21 CFR 870.1435, within the Cardiovascular review panel as a Class II device.