IQ NASAL MASK, MODEL 50160 REV. D

About This 510(k) Submission

K021534 is an FDA 510(k) clearance for the IQ NASAL MASK, MODEL 50160 REV. D, 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 July 2, 2002, 53 days after receiving the submission on May 10, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.