HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module

HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module is an FDA 510(k)-cleared medical device (K190205) manufactured by Edwards Lifesciences, 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 August 28, 2019. Regulation: 8.