eCARTv5 Clinical Deterioration Suite (“eCART”)

eCARTv5 Clinical Deterioration Suite (“eCART”) is an FDA 510(k)-cleared medical device (K233253) manufactured by Agilemd, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 20, 2024. Regulation: 8.