Clearance Summary
CADHEALTH SYSTEM, MODEL CHP-001 received FDA 510(k) clearance under submission number K002514, sponsored by Caduceus Health Care , 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 2001-05-31.
- Submission: K002514
- Applicant / Sponsor: Caduceus Health Care , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2910
- Decision date: 2001-05-31
Classification & Regulation
This clearance is catalogued under FDA product code DRG and 21 CFR 870.2910, within the Cardiovascular review panel as a Class II device.