510(k) K060273

SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837 by Sleepnet Corporation — Product Code BZD

K060273 is an FDA 510(k) premarket notification submitted by Sleepnet Corporation for the device "SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837". The FDA issued a decision of Substantially Equivalent on May 2, 2006. 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.