510(k) K110383

BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20 by A Plus Medical — Product Code BZD

K110383 is an FDA 510(k) premarket notification submitted by A Plus Medical for the device "BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20". The FDA issued a decision of Substantially Equivalent on August 1, 2011. 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.