ACCU-VENT(TM) WITH NEEDLE-PRO(TM)

ACCU-VENT(TM) WITH NEEDLE-PRO(TM) is an FDA 510(k)-cleared medical device (K912043) manufactured by Concord/Portex. This device is classified under the Anesthesiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 4, 1991. Regulation: 8.