510(k) K121321

HARD SHELL VENTED NASAL MASK by Sleepnet Corporation — Product Code BZD

K121321 is an FDA 510(k) premarket notification submitted by Sleepnet Corporation for the device "HARD SHELL VENTED NASAL MASK". The FDA issued a decision of Substantially Equivalent on November 30, 2012. 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.