510(k) K031064

INVACARE POLARIS EX CPAP, MODEL ISP3000 by Invacare Corp. — Product Code BZD

K031064 is an FDA 510(k) premarket notification submitted by Invacare Corp. for the device "INVACARE POLARIS EX CPAP, MODEL ISP3000". The FDA issued a decision of Substantially Equivalent on March 12, 2004. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Invacare Corp. has at least 10 other 510(k) clearances on record.