Clearance Summary
CARDIAC OUTPUT PULMONARY ARTERY CATHETER & MONITOR received FDA 510(k) clearance under submission number K925444, sponsored by Ami-Med Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1993-07-19.
- Submission: K925444
- Applicant / Sponsor: Ami-Med Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1240
- Decision date: 1993-07-19
Classification & Regulation
This clearance is catalogued under FDA product code DYG and 21 CFR 870.1240, within the Cardiovascular review panel as a Class II device.