ARC Intensive Care Information System (ARC System)

ARC Intensive Care Information System (ARC System) is an FDA 510(k)-cleared medical device (K220117) manufactured by Ordinatrum Solutions. 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 5, 2023. Regulation: 8.