Global Hypoperfusion Index (GHI) Algorithm

Global Hypoperfusion Index (GHI) Algorithm is an FDA 510(k)-cleared medical device (K231038) 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 July 25, 2023. Regulation: 8.