510(k) K241520

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

K241520 is an FDA 510(k) premarket notification submitted by Sleepnet Corporation for the device "Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask". The FDA issued a decision of Substantially Equivalent on June 27, 2024. 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.