510(k) K203601

Innova Nasal Non-Vented Mask by Sleepnet Corporation — Product Code BZD

K203601 is an FDA 510(k) premarket notification submitted by Sleepnet Corporation for the device "Innova Nasal Non-Vented Mask". The FDA issued a decision of Substantially Equivalent on April 30, 2021. 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.