Clearance Summary
CARDIOPHONE received FDA 510(k) clearance under submission number K894856, sponsored by Euro-American Marketing Group, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1990-01-18.
- Submission: K894856
- Applicant / Sponsor: Euro-American Marketing Group, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2920
- Decision date: 1990-01-18
Classification & Regulation
This clearance is catalogued under FDA product code DXH and 21 CFR 870.2920, within the Cardiovascular review panel as a Class II device.