Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask

About This 510(k) Submission

K190254 is an FDA 510(k) clearance for the Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Sleepnet Corporation (Hampton, US). The FDA issued a Cleared decision on July 5, 2019, 148 days after receiving the submission on February 7, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.