Innova Nasal Non-Vented Mask

About This 510(k) Submission

K203601 is an FDA 510(k) clearance for the Innova Nasal Non-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 April 30, 2021, 142 days after receiving the submission on December 9, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.