510(k) K031176

INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 by Invacare Corp. — Product Code BTT

K031176 is an FDA 510(k) premarket notification submitted by Invacare Corp. for the device "INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000". The FDA issued a decision of Substantially Equivalent on March 25, 2004. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Invacare Corp. has at least 10 other 510(k) clearances on record.