Clearance Summary
ECG HOME received FDA 510(k) clearance under submission number K012012, sponsored by H&C Medical Devices Spa. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2002-01-17.
- Submission: K012012
- Applicant / Sponsor: H&C Medical Devices Spa
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2920
- Decision date: 2002-01-17
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.