510(k) K241830

Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask by Sleepnet Corporation — Product Code BZD

K241830 is an FDA 510(k) premarket notification submitted by Sleepnet Corporation for the device "Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask". The FDA issued a decision of Substantially Equivalent on October 18, 2024. 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.