Vivo 45 LS

Vivo 45 LS is an FDA 510(k)-cleared medical device (K232365) manufactured by Oconnell Regulatory Consultants, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 18, 2025. Regulation: 8.