510(k) K201620

Luna® G3 BPAP 25A by 3B Medical, Inc. — Product Code BZD

K201620 is an FDA 510(k) premarket notification submitted by 3B Medical, Inc. for the device "Luna® G3 BPAP 25A". The FDA issued a decision of Substantially Equivalent on January 29, 2021. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. 3B Medical, Inc. has at least 9 other 510(k) clearances on record.