510(k) K161719

Salter Labs Bubble Humidifier by Salter Labs — Product Code BTT

K161719 is an FDA 510(k) premarket notification submitted by Salter Labs for the device "Salter Labs Bubble Humidifier". The FDA issued a decision of Substantially Equivalent on September 21, 2017. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Salter Labs has at least 10 other 510(k) clearances on record.