Clearance Summary
Multi-LinkTM X2 ECG Adapter and Leadwires received FDA 510(k) clearance under submission number K200510, sponsored by Vyaire Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-10-09.
- Submission: K200510
- Applicant / Sponsor: Vyaire Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2900
- Decision date: 2020-10-09
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.