Clearance Summary
HEART SYNC PEDIATRIC, MODEL PED-100 received FDA 510(k) clearance under submission number K081442, sponsored by Heart Sync, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2008-09-24.
- Submission: K081442
- Applicant / Sponsor: Heart Sync, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5300
- Decision date: 2008-09-24
Classification & Regulation
This clearance is catalogued under FDA product code LDD and 21 CFR 870.5300, within the Cardiovascular review panel as a Class II device.