Masimo Acoustic Respiration Sensors, infant and neonate

Masimo Acoustic Respiration Sensors, infant and neonate is an FDA 510(k)-cleared medical device (K173976) manufactured by Masimo Corporation. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 4, 2018. Regulation: 8.