iQ 2 Nasal Mask, Phantom 2 Nasal Mask

About This 510(k) Submission

K211274 is an FDA 510(k) clearance for the iQ 2 Nasal Mask, Phantom 2 Nasal 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 January 10, 2022, 258 days after receiving the submission on April 27, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.