Clearance Summary
CARDIAC OUTPUT COMPUTER (MODEL COC-100) received FDA 510(k) clearance under submission number K760844, sponsored by B-D Electrodyne. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1976-11-12.
- Submission: K760844
- Applicant / Sponsor: B-D Electrodyne
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1435
- Decision date: 1976-11-12
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.