510(k) K013306

MINIME NASAL MASK, MODEL P/N 50220 by Sleepnet Corporation — Product Code BZD

K013306 is an FDA 510(k) premarket notification submitted by Sleepnet Corporation for the device "MINIME NASAL MASK, MODEL P/N 50220". The FDA issued a decision of Substantially Equivalent on November 2, 2001. 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.