510(k) K022650

APEX MEDICAL CPAP RT 21XX by Apex Medical Corp. — Product Code BZD

K022650 is an FDA 510(k) premarket notification submitted by Apex Medical Corp. for the device "APEX MEDICAL CPAP RT 21XX". The FDA issued a decision of Substantially Equivalent on February 4, 2004. 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.