510(k) K150111

Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series by Apex Medical Corp. — Product Code BZD

K150111 is an FDA 510(k) premarket notification submitted by Apex Medical Corp. for the device "Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series". The FDA issued a decision of Substantially Equivalent on September 15, 2015. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Apex Medical Corp. has at least 10 other 510(k) clearances on record.