510(k) K083656

APEX MEDICAL XT AUTO CPAP 9S-005200 by Apex Medical Corp. — Product Code BZD

K083656 is an FDA 510(k) premarket notification submitted by Apex Medical Corp. for the device "APEX MEDICAL XT AUTO CPAP 9S-005200". The FDA issued a decision of Substantially Equivalent on April 22, 2009. 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.