510(k) K190254

Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask by Sleepnet Corporation — Product Code BZD

K190254 is an FDA 510(k) premarket notification submitted by Sleepnet Corporation for the device "Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask". The FDA issued a decision of Substantially Equivalent on July 5, 2019. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Sleepnet Corporation has at least 10 other 510(k) clearances on record.