510(k) K211274

iQ 2 Nasal Mask, Phantom 2 Nasal Mask by Sleepnet Corporation — Product Code BZD

K211274 is an FDA 510(k) premarket notification submitted by Sleepnet Corporation for the device "iQ 2 Nasal Mask, Phantom 2 Nasal Mask". The FDA issued a decision of Substantially Equivalent on January 10, 2022. 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.