Neonatal ConchaSmart Breathing Circuits

Neonatal ConchaSmart Breathing Circuits is an FDA 510(k)-cleared medical device (K173280) manufactured by Teleflexmedical, 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 August 1, 2018. Regulation: 8.