510(k) K131912

CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN by Teleflex, Inc. — Product Code BTT

K131912 is an FDA 510(k) premarket notification submitted by Teleflex, Inc. for the device "CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN". The FDA issued a decision of Substantially Equivalent on March 6, 2014. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Teleflex, Inc. has at least 9 other 510(k) clearances on record.