510(k) K062664

HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004 by Apex Medical Corp. — Product Code BTT

K062664 is an FDA 510(k) premarket notification submitted by Apex Medical Corp. for the device "HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004". The FDA issued a decision of Substantially Equivalent on December 6, 2006. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Apex Medical Corp. has at least 10 other 510(k) clearances on record.