510(k) K041828

APEX MEDICAL CPAP MODEL 9S-003 by Apex Medical Corp. — Product Code BZD

K041828 is an FDA 510(k) premarket notification submitted by Apex Medical Corp. for the device "APEX MEDICAL CPAP MODEL 9S-003". The FDA issued a decision of Substantially Equivalent on July 30, 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.