HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable

HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable is an FDA 510(k)-cleared medical device (K223127) manufactured by Edwards Lifeciences, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 6, 2022. Regulation: 8.