510(k) K173976

Masimo Acoustic Respiration Sensors, infant and neonate by Masimo Corporation — Product Code BZQ

K173976 is an FDA 510(k) premarket notification submitted by Masimo Corporation for the device "Masimo Acoustic Respiration Sensors, infant and neonate". The FDA issued a decision of Substantially Equivalent on September 5, 2018. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Masimo Corporation has at least 10 other 510(k) clearances on record.