510(k) K232836

Family of DIMAR DMAX NIV masks by Dimar S.P.A. — Product Code CBK

K232836 is an FDA 510(k) premarket notification submitted by Dimar S.P.A. for the device "Family of DIMAR DMAX NIV masks". The FDA issued a decision of Substantially Equivalent on August 14, 2024. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895.