VENTILATOR MODEL BV-300 INFANT

VENTILATOR MODEL BV-300 INFANT is an FDA 510(k)-cleared medical device (K790199) manufactured by Bourns Medical Systems, 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 April 12, 1979. Regulation: 8.