Clearance Summary
DESERET THERMODILUTION CARDIAC OUTPUT received FDA 510(k) clearance under submission number K841967, sponsored by Parke-Davis Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1985-08-19.
- Submission: K841967
- Applicant / Sponsor: Parke-Davis Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1435
- Decision date: 1985-08-19
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.