FDA 510(k) Applications Submitted by Edwards Lifeciences, LLC

FDA 510(k) Number Submission Date Device Name Applicant
K183646 12/26/2018 Acumen Hypotension Prediction Index û EV1000 Clinical Platform, Acumen Hypotension Prediction Index û HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index û HemoSphere Advanced Monitoring Platform - Pressure Edwards Lifeciences, LLC
K223127 10/03/2022 HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable Edwards Lifeciences, LLC
K183413 12/10/2018 TruWave Disposable Pressure Transducer Edwards Lifeciences, LLC


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact