510(k) K063806

SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED by Sleepnet Corporation — Product Code CBK

K063806 is an FDA 510(k) premarket notification submitted by Sleepnet Corporation for the device "SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED". The FDA issued a decision of Substantially Equivalent on May 17, 2007. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Sleepnet Corporation has at least 10 other 510(k) clearances on record.