510(k) K190533

Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented by Sleepnet Corporation — Product Code CBK

K190533 is an FDA 510(k) premarket notification submitted by Sleepnet Corporation for the device "Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented". The FDA issued a decision of Substantially Equivalent on July 26, 2019. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Sleepnet Corporation has at least 10 other 510(k) clearances on record.