510(k) K120035

APEX MEDICAL ICH CPAP SERIES (9S-007XXX) by Apex Medical Corp. — Product Code BZD

K120035 is an FDA 510(k) premarket notification submitted by Apex Medical Corp. for the device "APEX MEDICAL ICH CPAP SERIES (9S-007XXX)". The FDA issued a decision of Substantially Equivalent on May 16, 2012. 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.