510(k) K112079

APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720 by Apex Medical Corp. — Product Code BZD

K112079 is an FDA 510(k) premarket notification submitted by Apex Medical Corp. for the device "APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720". The FDA issued a decision of Substantially Equivalent on December 6, 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.