Clearance Summary
MEDICK MHM200 PERSONAL HEART MONITOR received FDA 510(k) clearance under submission number K063339, sponsored by Medick Healthcare , 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 2007-06-29.
- Submission: K063339
- Applicant / Sponsor: Medick Healthcare , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2007-06-29
Classification & Regulation
This clearance is catalogued under FDA product code MLO and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.