510(k) K143677

DeVilbiss Intellipap2/DeVilbiss BLUE by Devilbiss Healthcare, LLC — Product Code BZD

K143677 is an FDA 510(k) premarket notification submitted by Devilbiss Healthcare, LLC for the device "DeVilbiss Intellipap2/DeVilbiss BLUE". The FDA issued a decision of Substantially Equivalent on September 18, 2015. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Devilbiss Healthcare, LLC has at least 6 other 510(k) clearances on record.