510(k) K251847

Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask by Sleepnet Corporation — Product Code BZD

K251847 is an FDA 510(k) premarket notification submitted by Sleepnet Corporation for the device "Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask". The FDA issued a decision of Substantially Equivalent on January 15, 2026. 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.