510(k) K220145

Monaghan medical filtered mouthpiece kit by Monaghan Medical Corporation — Product Code CAF

K220145 is an FDA 510(k) premarket notification submitted by Monaghan Medical Corporation for the device "Monaghan medical filtered mouthpiece kit". The FDA issued a decision of Substantially Equivalent on August 24, 2023. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Monaghan Medical Corporation has at least 1 other 510(k) clearance on record.