Clearance Summary
ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH received FDA 510(k) clearance under submission number K032200, sponsored by Remco Italia S.P.A.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2003-10-03.
- Submission: K032200
- Applicant / Sponsor: Remco Italia S.P.A.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2003-10-03
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.