Clearance Summary
HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform received FDA 510(k) clearance under submission number K211465, sponsored by Edwards Lfesciences. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2021-07-08.
- Submission: K211465
- Applicant / Sponsor: Edwards Lfesciences
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1425
- Decision date: 2021-07-08
Classification & Regulation
This clearance is catalogued under FDA product code DQK and 21 CFR 870.1425, within the Cardiovascular review panel as a Class II device.