VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER

VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER is an FDA 510(k)-cleared medical device (K092687) manufactured by A Plus Medical. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 22, 2009. Regulation: 8.