Clearance Summary
ECG Cables and Leadwires received FDA 510(k) clearance under submission number K201359, sponsored by Xinkang Medical Instrument 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 2020-10-01.
- Submission: K201359
- Applicant / Sponsor: Xinkang Medical Instrument Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2900
- Decision date: 2020-10-01
Classification & Regulation
This clearance is catalogued under FDA product code DSA and 21 CFR 870.2900, within the Cardiovascular review panel as a Class II device.