Clearance Summary
CARDIOMD-AC received FDA 510(k) clearance under submission number K040616, sponsored by Danish Diagnostic Development A/S. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2004-03-24.
- Submission: K040616
- Applicant / Sponsor: Danish Diagnostic Development A/S
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1200
- Decision date: 2004-03-24
Classification & Regulation
This clearance is catalogued under FDA product code KPS and 21 CFR 892.1200, within the Radiology review panel as a Class II device.