510(k) K173367

MC 300* Nebulizer by Trudell Medical International — Product Code CAF

K173367 is an FDA 510(k) premarket notification submitted by Trudell Medical International for the device "MC 300* Nebulizer". The FDA issued a decision of Substantially Equivalent on February 28, 2018. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Trudell Medical International has at least 8 other 510(k) clearances on record.