Clearance Summary
THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR received FDA 510(k) clearance under submission number K103706, sponsored by Applied Cardiac Systems, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-08-24.
- Submission: K103706
- Applicant / Sponsor: Applied Cardiac Systems, Inc.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2011-08-24
Classification & Regulation
This clearance is catalogued under FDA product code QYX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.