Clearance Summary
SMARTHEART received FDA 510(k) clearance under submission number K113514, sponsored by Shl Telemedicine International , 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 2012-02-22.
- Submission: K113514
- Applicant / Sponsor: Shl Telemedicine International , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2920
- Decision date: 2012-02-22
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.