Clearance Summary
HORIZON CARDIOLOGY ECG MANAGEMENT received FDA 510(k) clearance under submission number K113515, sponsored by Mckesson Israel , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2012-03-16.
- Submission: K113515
- Applicant / Sponsor: Mckesson Israel , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1425
- Decision date: 2012-03-16
Classification & Regulation
This clearance is catalogued under FDA product code DQK and 21 CFR 870.1425, within the Cardiovascular review panel as a Class II device.