510(k) K120757

SLEEPWEAVER ELAN NASAL CPAP MASK by Circadiance, LLC — Product Code BZD

K120757 is an FDA 510(k) premarket notification submitted by Circadiance, LLC for the device "SLEEPWEAVER ELAN NASAL CPAP MASK". The FDA issued a decision of Substantially Equivalent on April 24, 2012. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Circadiance, LLC has at least 4 other 510(k) clearances on record.