HARD SHELL VENTED NASAL MASK

About This 510(k) Submission

K121321 is an FDA 510(k) clearance for the HARD SHELL VENTED NASAL MASK, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Sleepnet Corporation (Bonita Springs, US). The FDA issued a Cleared decision on November 30, 2012, 212 days after receiving the submission on May 2, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.