Clearance Summary
Change Healthcare Cardiology Hemodynamics received FDA 510(k) clearance under submission number K230881, sponsored by Change Healthcare Israel , 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 2023-09-11.
- Submission: K230881
- Applicant / Sponsor: Change Healthcare Israel , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2023-09-11
Classification & Regulation
This clearance is catalogued under FDA product code MWI and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.