Clearance Summary
Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes received FDA 510(k) clearance under submission number K221782, sponsored by Merit Medical Pte. , 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 2023-03-17.
- Submission: K221782
- Applicant / Sponsor: Merit Medical Pte. , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2850
- Decision date: 2023-03-17
Classification & Regulation
This clearance is catalogued under FDA product code DRS and 21 CFR 870.2850, within the Cardiovascular review panel as a Class II device.