VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101

VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101 is an FDA 510(k)-cleared medical device (K964360) manufactured by Novametrix 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 3, 1997. Regulation: 8.