510(k) K952823

FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE by Icor AB — Product Code BYD

K952823 is an FDA 510(k) premarket notification submitted by Icor AB for the device "FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE". The FDA issued a decision of Substantially Equivalent on July 13, 1995. The device falls under product code BYD (Condenser, Heat And Moisture (Artificial Nose)), a Class I device regulated under 21 CFR 868.5375. Icor AB has at least 10 other 510(k) clearances on record.