510(k) K093716

BABI PLUS INFANT NASAL CANNULA SYSTEM by A Plus Medical — Product Code BZD

K093716 is an FDA 510(k) premarket notification submitted by A Plus Medical for the device "BABI PLUS INFANT NASAL CANNULA SYSTEM". The FDA issued a decision of Substantially Equivalent on May 13, 2010. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. A Plus Medical has at least 6 other 510(k) clearances on record.