510(k) K223551

Sterile Water for Inhalation in 1L Flexoval ® bottles. by Hometa, Inc. — Product Code BTT

K223551 is an FDA 510(k) premarket notification submitted by Hometa, Inc. for the device "Sterile Water for Inhalation in 1L Flexoval ® bottles.". The FDA issued a decision of Substantially Equivalent on August 3, 2023. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450.