Clearance Summary
ECG Acquisition Systems received FDA 510(k) clearance under submission number K163607, 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 2017-12-15.
- Submission: K163607
- Applicant / Sponsor: Vales & Hills Biomedical Tech. , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2017-12-15
Classification & Regulation
This clearance is catalogued under FDA product code DPS and 21 CFR 870.2340, within the Cardiovascular review panel as a Class II device.