MINIME NASAL MASK, MODEL P/N 50220

About This 510(k) Submission

K013306 is an FDA 510(k) clearance for the MINIME NASAL MASK, MODEL P/N 50220, 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 November 2, 2001, 29 days after receiving the submission on October 4, 2001. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.