510(k) K210126

Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% by The Ritedose Corporation — Product Code CAF

K210126 is an FDA 510(k) premarket notification submitted by The Ritedose Corporation for the device "Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%". The FDA issued a decision of Substantially Equivalent on December 3, 2021. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630.