Clearance Summary
CARDIOLINE AR 600, AR 1200, AR 2100 received FDA 510(k) clearance under submission number K051534, sponsored by Et Medical Devices Spa. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2005-10-05.
- Submission: K051534
- Applicant / Sponsor: Et Medical Devices Spa
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2005-10-05
Classification & Regulation
This clearance is catalogued under FDA product code DPS and 21 CFR 870.2340, within the Cardiovascular review panel as a Class II device.