Clearance Summary
Acumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform - Pressure received FDA 510(k) clearance under submission number K183646, sponsored by Edwards Lifeciences, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2019-05-21.
- Submission: K183646
- Applicant / Sponsor: Edwards Lifeciences, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2210
- Decision date: 2019-05-21
Classification & Regulation
This clearance is catalogued under FDA product code QAQ and 21 CFR 870.2210, within the Cardiovascular review panel as a Class II device.