510(k) K232523

Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% by Mankind Pharma Limited — Product Code CAF

K232523 is an FDA 510(k) premarket notification submitted by Mankind Pharma Limited for the device "Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%". The FDA issued a decision of Substantially Equivalent on April 10, 2024. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630.