Clearance Summary
CV3000 HOLTER ANALYSIS SYSTEM received FDA 510(k) clearance under submission number K131897, sponsored by Vales & Hills Biomedical Tech. , 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 2013-11-26.
- Submission: K131897
- Applicant / Sponsor: Vales & Hills Biomedical Tech. , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2013-11-26
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.