510(k) K131901

IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 by 3B Medical, Inc. — Product Code BZD

K131901 is an FDA 510(k) premarket notification submitted by 3B Medical, Inc. for the device "IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2". The FDA issued a decision of Substantially Equivalent on December 23, 2013. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. 3B Medical, Inc. has at least 9 other 510(k) clearances on record.