Clearance Summary
AMLUCK, YA HORNG received FDA 510(k) clearance under submission number K042581, sponsored by Ya Horng Electronic Co., 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 2004-10-13.
- Submission: K042581
- Applicant / Sponsor: Ya Horng Electronic Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2004-10-13
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.