SafeT T-Piece Resuscitator

SafeT T-Piece Resuscitator is an FDA 510(k)-cleared medical device (K173373) manufactured by Ventlab, LLC. 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 15, 2018. Regulation: 8.