PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS

PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS is an FDA 510(k)-cleared medical device (K072290) manufactured by Dima Italia Srl. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 28, 2008. Regulation: 8.