SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837

About This 510(k) Submission

K060273 is an FDA 510(k) clearance for the SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Sleepnet Corporation (Manchester, US). The FDA issued a Cleared decision on May 2, 2006, 89 days after receiving the submission on February 2, 2006. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.