510(k) K203400

Corrugated tube with mouthpiece accessory by Trudell Medical International — Product Code CAF

K203400 is an FDA 510(k) premarket notification submitted by Trudell Medical International for the device "Corrugated tube with mouthpiece accessory". The FDA issued a decision of Substantially Equivalent on June 14, 2021. 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.